Michael Barbella, Managing Editor03.19.24
SNAP. CRACKLE. POP.
Elizabeth Reese is not a doctor. She’s a labor and delivery nurse, charged with bringing new life into the world. Yet she knows enough about the human body to recognize a few of its warning signs.
And one of those signs was coming from her shoulder.
SNAP. CRACKLE. POP.
Reese heard that sound every time she lifted her arms above her head.
Hoisting her surfboard to and from her car roof.
SNAP. CRACKLE. POP.
Hiking the San Juan Capistrano trails.
SNAP. CRACKLE. POP.
Scuba diving and snorkeling off the southern California coast.
SNAP. CRACKLE. POP.
SNAP. CRACKLE. POP.
“You can tell I’m an outdoor person. Every time I put my hands over my head, I would have snapping, crackling, and popping,” the grandmother of three recalled in an online video. “And I would hear this grinding noise all the time, so it was very hard for me to put my hands up over my head.”
When the frustration became too great—and the internal Rice Krispies symphony too maddening—Reese sought advice from Ari R. Youderian, M.D., an orthopedic surgeon who treats shoulder, upper arm, and elbow fractures, arthritis, dislocations, and complex injuries/tears.
Dr. Youderian recommended that Reese replace her failing joint with Exactech Inc.’s Equinoxe shoulder system, which uses digital navigation technology to pre-plan procedures and more accurately place shoulder implants. ExactechGPS gives surgeons a real-time view of retroversion and inclination; reaming and drilling depth; and screw placement; enabling them to adjust the surgical plan intraoperatively. The tool also allows surgeons to choose precise implants and sizes for both the scapula and humerus based on individual patient anatomy—a feat that can help minimize complications and improve implant durability.
Surgeons have used Exactech’s Equinoxe Planning App since its launch to plot more than 50,000 shoulder cases and executed their plans in 30,000-plus cases using GPS, according to the company. Exactech has overhauled its Planning App software twice in the last two years—once in July 2022, introducing a redesigned and improved user interface as well as access to the machine learning-based clinical decision support tool Predict+, and again last spring, releasing a new tool that enables surgeons and hospital staff to upload shoulder CT scans for reconstruction through the web.
“The Exactech Equinoxe shoulder system is...based on a culture of sound research and engineering, and it’s really allowed me to provide patients with a very advanced option for their shoulder,” Dr. Youderian noted in the same online video. “In trying to determine what to use for her [Reese], the ExactechGPS system was a great option because I really wanted to be precise with her. I wanted to make sure that we put the parts exactly where we needed them to be so that she could get back out there and do both her job and get back to her passions.”
Reese is back to her passions these days—both old and new. She’s surfing with her grandsons, scuba diving, taking photographs, and caring for her new rescue dog.
“I decided that I needed something to inspire me to go out and get walking and give me something to take care of. So I went out and got another rescue puppy so that I would continue to be active,” Reese said. “I can actually pick up my [surf]board and put it over my head, which is very exciting [but] the most exciting thing was after about five months, I was able to actually put the big lens on my camera and go back out and start taking pictures again.”
Now, the only sounds Reese hears are those of her camera—click-click-click—and its subjects.
No more SNAP. CRACKLE. POP.
Success stories like Reese’s have become more commonplace in recent years as athletes seek redemption from sports-related injuries and geriatrics seek refuge from age-associated medical conditions (bursitis, osteoarthritis, frozen shoulder). Such motivations have helped the shoulder replacement sector capture the lion’s share of the global upper extremities market, accounting for a 59.5% share in 2022, according to Grand View Research. The market intelligence firm valued the worldwide shoulder replacement market at $400.81 million last year and envisions it expanding 8.2% annually through 2030.
“Like most orthopedic market segments, volumes have shown strong increases, both from the pandemic recovery as well as what appear to be sustainable demand for prolonged activity,” said Kenneth Ross, business development director at Precision Edge Surgical Products LLC, a Sault Sainte Marie, Mich.-based contract manufacturer of fine surgical components, cutting tools, and accessories. “More and more companies are taking on reverse shoulders in their portfolio. I recently spoke to a customer that said they planned to begin internal development on their first total shoulder product line, with the expectation of completion in approximately four years. So the commitment is there.”
It’s there in a big way, too: Most major orthopedic implant manufacturers have made firm commitments to the world’s shoulder replacement patients, offering them numerous alternatives for reconstruction. Exactech, for example, gives new joint hopefuls primary, reverse, and stemless shoulder options, as well as stem preservation, humeral reconstruction prosthesis, and head resurfacing choices (all Equinoxe).
Catalyst OrthoScience, on the other hand, gives patients some flexibility with the Catalyst Stemmed CSR TSA System, a product that can convert to a reverse shoulder as needed. The Naples, Fla.-headquartered firm claims to be the only company to offer anatomically shaped non-spherical heads in both stemmed and stemless solutions.
Flexible options also are available from Smith+Nephew plc. The U.K. firm’s AETOS Shoulder System is intended for both anatomic and reverse total shoulder arthroplasty; the system’s Meta stem is designed for stability with metaphyseal fixation and an inlay collar. Cleared by the U.S. Food and Drug Administration (FDA) in June 2023, the AETOS System requires fewer steps for conversion and fewer instruments for primary anatomic and reverse procedures.
“After using the system for the past several months, I can say the AETOS Shoulder System is a game-changer,” Charles M. Jobin, M.D., an orthopedic surgeon at Columbia University Irving Medical Center, said upon the AETOS’ full commercial launch in February (2024). “With the stability of its Meta Stem, the flexibility the system provides, and streamlined instrumentation, it’s a great solution not only benefitting patients but surgeons alike.”
Another mutually beneficial shoulder fix proffered by Smith+Nephew is the REGENETEN Bioinductive Implant, a collagen-based material that stimulates the body’s natural healing process to repair rotator cuff tears. Roughly the size of a postage stamp, the implant is made from highly purified bovine Achilles tendon and helps facilitate new tendon-like tissue formation in the affected area.
Recent study data substantiate REGENETEN’s efficacy: One-year trial results published in December 2023 suggest that medium and large full-thickness rotator cuff tears repaired and augmented with the REGENETEN implant produced better tendon healing compared with the standard of care. The results showed a significantly lower re-tear rate (8.3% REGENETEN vs. 25.8% for standard of care), a three-times lower re-tear risk, and no difference in the number of serious or minor complications.
In the race to market for robotic-assisted shoulder surgery. Zimmer Biomet Holdings Inc. crossed the finish line first, receiving FDA 510(k) clearance in late February for the ROSA Shoulder System.
Billed as the world’s first robotic-assisted surgical system for shoulder replacement, ROSA Shoulder is the fourth application in the orthopedic behemoth’s robotics portfolio, which includes ROSA Knee System for total knee arthroplasty and ROSA Hip System for total hip replacement.
ROSA Shoulder enables surgeons to perform total shoulder replacements using anatomic or reverse techniques, and improve implant placement accuracy. It is one of the only systems that reproduces humeral head resectioning and eases the insertion of instruments into incisions by requiring no pin in the glenoid’s center during procedures. Like all Zimmer Biomet robotics applications, ROSA Shoulder is designed to support data-informed physician decision-making based on patients’ unique anatomies.
Pre-operatively, ROSA Shoulder integrates with the company’s newly-released Signature ONE Surgical Planning System 2.0, which uses a 3D image-based approach to visualization, surgical planning, and patient-specific guide creation. During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute, and validate personalized plans for glenoid and humeral placement.
ROSA Shoulder will be commercially available in the United States in the second half of this year, and will work with the mymobility Digital Care Management Platform to bolster the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.
“ROSA Shoulder is just the first step in demonstrating what innovation can bring to the extremity market,” noted Nnamdi Njoku, president of Sports Medicine, Surgical, Upper Extremities & Restorative Therapies at Zimmer Biomet. “As digital tools continue to evolve in the extremity space, emerging digital solutions like AI, patient-specific implants, orthobiologics, and increasing surgical robots in ASCs will create new opportunities for preparing surgeons for patient-specific surgeries while improving access to high-quality care for patients, uniformly helping all surgery players in the long run.”
“We are seeing a need in the market for robotic solutions providing real-time insights and feedback in the theater and an increase in interest in solutions proven to optimize outcomes and improve the standard of care,” he continued. “We are currently looking at an extremities landscape where every major player is either developing or has developed their own robotic platform for orthopedic extremities surgery, which will improve the insights surgeons receive throughout the procedure. Thanks to expanding technologies like robotics, navigation, and MR [mixed reality] solutions, patients will eventually have more options to receive the highest quality care possible, which could fundamentally disrupt the market depending on how key stakeholders integrate top-of-industry insights into their solutions.”
That integration thus far has spawned advancements in customized implants, minimally invasive surgical (MIS) techniques, pre-operative planning/surgical navigation software, and sterile procedure kits.
Lewisville, Texas-based Orthofix Medical Inc. has taken the lead in the latter category, expanding its sterile kit lineup in recent years with the latest additions—the Galaxy Fixation Gemini and CalcFix Plus Calcaneal Minifixator systems—entering the market last year.
The Gemini system—the newest Galaxy product family member—is offered in several sterile procedure kit configurations as a quick off-the-shelf solution for treating trauma-related lower and upper limb fractures. Specifically, the Galaxy Gemini ankle kit is marketed as the only pin-to-bar system with specific clamps available in a sterile kit configuration; Orthofix claims the design gives surgeons more efficient lower extremity trauma solutions during time-sensitive circumstances. The ankle kit features a double multi-screw clamp to facilitate the rapid insertion of tibial half-pins and is complemented by the foot support and first metatarsal sterile kits for a more robust construct.
The CalcFix Plus Calcaneal Minifixator System is an updated version of the original CalcFix Fixator device, which treats calcaneal fractures using a more minimally invasive external fixation approach compared with internal fixation. The CalcFix Plus includes design upgrades that reduce the required number of operative steps.
“Continued healthcare cost pressures and preserving sterility in the OR are strong market drivers, leading to more companies offering sterile packaged procedural solutions,” Kim Elting, Orthofix Global Orthopedics president, told ODT. “While becoming a requirement in Europe, there is also a trend in the United States for sterile procedure kits, particularly in trauma settings where time is critical and relying on instrument trays to be processed can create delays and compromise the patient’s surgery. Because of these factors, we are continuing to invest in sterile kit offerings, building on our already industry-leading portfolio of single-use sterile pack solutions, with over 50 different configurations now available worldwide.”
Paragon 28 Inc. followed Orthofix’s lead earlier this year, bolstering its flatfoot, bunion/forefoot, and hallux valgus offerings through minimally invasive solutions.
In late January, the Englewood, Colo.-based company launched the Mister Tendon System, an instrument that enables surgeons to perform a distal cut of the flexor hallucis longus or flexor digitorum longus tendon through a minimally invasive incision, and harvest enough tendon for transfer procedures. Besides the harvester, the Mister Tendon system features an accessory dilator instrument for bluntly dissecting soft tissue, which enhances harvester access without causing additional damage. Using the Mister Tendon system in a minimally invasive approach reportedly can help improve healing and facilitate recovery in flatfoot reconstruction.
Four days after releasing the Mister Tendon System, Paragon 28 debuted the FJ2000 Power Console and Burr System, a tool developed for various minimally invasive, open foot and ankle procedures.
The FJ2000 Power Console and Burr System allows for quick and efficient setup at the start of each procedure. The system has three pre-set options, including a low speed, high torque setting for reducing thermal necrosis during bone and joint preparation, and preserving healthy bone healing.
The FJ2000’s single-use handpieces and selection of burrs and instruments are housed in a sterile packed kit. As a single-use option, the FJ2000 allows surgeons to be more flexible and efficient; it also can help prevent costly delays from the wear and sterilization associated with traditional reusable power systems.
Just two days after the FJ2000’s Jan. 30 introduction, Paragon 28 unveiled the PRECISION MIS Bunion System, which allows surgeons to complete a distal metatarsal osteotomy using a minimally invasive surgical (MIS) technique. The system features an outrigger designed for controlled tri-planar correction including metatarsal head translation and derotation, and distal metatarsal articular angle adjustment. The system also includes instruments to facilitate a freehand technique and cannulated chamfer screws for fixation that help align the metatarsal head near the first metatarsal cortex. This minimally invasive technique is joint preserving, and screw placement is designed to reduce the chance of soft tissue irritation.
“Minimally invasive surgery is one of the main topics of conversation and it’s featured in a majority of medical education programs,” stated Michael Rankin, vice president of Marketing and Medical Education, Foot & Ankle, at Stryker Corp. “There is currently a small percentage of procedures conducted minimally invasively—about 10 percent—but it’s one of the fastest-growing subsegments in the foot and ankle space. The learning curve for the surgeon is much longer, but minimally invasive techniques can help reduce trauma to the body and get patients back to function quickly. Minimally invasive surgery is really hitting the mainstream now and that 10 percent is going to accelerate in the coming years. We are staying ahead of the game with the PROstep MIS Lapidus system.”
Launched last fall, the PROstep MIS Lapidus is a new internal fixation system intended for treating bunions using an MIS hallux valgus deformity reduction and subsequent first metatarsal cuneiform joint fusion. The new technology features MIS joint preparation, triplanar reduction, and a three-screw construct designed to create a tension band for biomechanical stability.
Benefits of the PROstep MIS Lapidus system include a 2.5% decrease in recurrence compared to open Lapidus procedures; a 9% reduction in non-union rates due to MIS Lapidus joint preparation; a 76% reduction in scar size compared to open bunion correction procedures; and less post-op opioid use compared to open Lapidus procedures.
“The shift towards minimally invasive procedures such as arthroscopy have become increasingly common in extremity surgeries, reducing tissue damage, promoting quicker recovery, and enhancing overall outcomes,” said Mike Couch, business development manager at Precision Medical Technologies, an ISO 13485:2003-certified contract manufacturer of orthopedic implants and instruments headquartered in Warsaw, Ind. “Advances in 3D printing technology allow for the creation of patient-specific implants tailored to individual anatomy, improving the fit and function of implants. This has led to less off-label use of products in the operating room and better patient outcomes.”
Artificial intelligence (AI) technology is fostering better patient outcomes too. Exactech’s Predict+, for instance, uses machine learning to predict individual patient outcomes after shoulder replacement surgery to augment surgeons’ decision-making. The software is designed to better inform physicians about expected achievable outcomes after shoulder arthroplasty, based on the clinical experience documented within the world’s largest single shoulder prosthesis outcomes database—consisting of more than 10,000 patients.
Exactech also is conducting several new studies that are using machine learning to analyze CT image-based muscle features to measure muscle size, shape, and quality. The measurements will be used to improve the accuracy of shoulder arthroplasty outcomes predictions.
“Machine learning algorithms can analyze data and optimize prosthetic settings, ensuring a better fit, improved comfort, and enhanced functionality for individual users,” said Dario Renggli, business development manager at high-precision drive systems developer maxon group.
Zimmer Biomet has incorporated AI into the OR to help optimize surgical workflows and procedural efficiencies. Its intelligent, integrated operating room—Omni Suite—automates manual tasks and streamlines unnecessary technology and redundant hardware. The AI feature uses cameras to automatically recognize and timestamp key OR workflow milestones, including patient entry and exit, door count, anesthesia start/stop, surgery, and cleaning. Surgical teams are guided through a process to help optimize OR workflow based on real-time access to workflow metrics.
DePuy Synthes, meanwhile, is leveraging AI to help improve bony deformities in the foot and ankle.
“We are harnessing the power of AI within the elective foot and ankle space and are currently in a limited launch of VirtuGuide—a differentiated, pre-operative Patient-Matched Lapidus correction system powered by predictive AI software,” explained Oray Boston Jr., worldwide president, DePuy Synthes Trauma, Extremities, Craniomaxillofacial, Animal Health, and Sports. “Our VirtuGuide AI Patient-Matched Platform provides physicians with an automated patient analysis to treat bony deformities of the foot and ankle. The AI software outputs the single deformity correction instrument needed to treat that specific patient, which allows for intra-operative simplicity, fewer instruments, and reduced surgery time. This is truly an exciting advancement for surgeons and their patients.”
AI also is helping generate excitement among surgeons and patients well before the latter group even enters the operating room. Pre-operative planning/navigation software has now become fairly standard with most extremity solutions due to its proficiency in implant placement accuracy and procedural precision.
Earlier this year, Stryker expanded its Prophecy Surgical Planning System to the entire foot, providing clinicians with a more integrated approach and complete view of the foot around the ankle.
Orthofix’s OrthoNext platform system overlays Orthofix product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template.The OrthoNext software enables surgeons to accurately plan an osteotomy position and visualize an implant in relation to the anatomy. It also streamlines the selection of a precise device size and enables optimal positioning for the patient’s body before the surgical procedure.
“AI is contributing to training simulations that improve procedure quality and efficiencies,” stated Brad Womble, senior director of Strategy and Business Development at Cirtec, a full-service outsource partner.
Such improvements are critical as orthopedic procedures increasingly shift from the hospital to ambulatory surgical centers (ASCs). Numerous factors are contributing to this shift, including advances in technology, patient and physician preference, and regulatory and reimbursement changes.
“Shifting procedures towards ambulatory surgical centers is rapidly redefining the treatment site of care landscape in extremities surgery, and is continuing to reshape how medtech companies introduce solutions to the market,” Njoku said. “With the growing demand for efficiency and better patient outcomes, medtech companies are beginning to see themselves as key partners for ASCs and are presenting patient-focused integrated technology solutions. Ultimately, with the goal to accelerate growth in the ASC space. These solutions, like robotics, are also emerging at a time when patients are returning to the surgery room post-pandemic for elective extremities procedures at high volumes, meaning the need for customized solutions and surgical robotics assistants has never been higher. The time is perfect for companies to introduce their enabling technology solutions to the extremities market and to address these demands.”
Elizabeth Reese is not a doctor. She’s a labor and delivery nurse, charged with bringing new life into the world. Yet she knows enough about the human body to recognize a few of its warning signs.
And one of those signs was coming from her shoulder.
SNAP. CRACKLE. POP.
Reese heard that sound every time she lifted her arms above her head.
Hoisting her surfboard to and from her car roof.
SNAP. CRACKLE. POP.
Hiking the San Juan Capistrano trails.
SNAP. CRACKLE. POP.
Scuba diving and snorkeling off the southern California coast.
SNAP. CRACKLE. POP.
SNAP. CRACKLE. POP.
“You can tell I’m an outdoor person. Every time I put my hands over my head, I would have snapping, crackling, and popping,” the grandmother of three recalled in an online video. “And I would hear this grinding noise all the time, so it was very hard for me to put my hands up over my head.”
When the frustration became too great—and the internal Rice Krispies symphony too maddening—Reese sought advice from Ari R. Youderian, M.D., an orthopedic surgeon who treats shoulder, upper arm, and elbow fractures, arthritis, dislocations, and complex injuries/tears.
Dr. Youderian recommended that Reese replace her failing joint with Exactech Inc.’s Equinoxe shoulder system, which uses digital navigation technology to pre-plan procedures and more accurately place shoulder implants. ExactechGPS gives surgeons a real-time view of retroversion and inclination; reaming and drilling depth; and screw placement; enabling them to adjust the surgical plan intraoperatively. The tool also allows surgeons to choose precise implants and sizes for both the scapula and humerus based on individual patient anatomy—a feat that can help minimize complications and improve implant durability.
Surgeons have used Exactech’s Equinoxe Planning App since its launch to plot more than 50,000 shoulder cases and executed their plans in 30,000-plus cases using GPS, according to the company. Exactech has overhauled its Planning App software twice in the last two years—once in July 2022, introducing a redesigned and improved user interface as well as access to the machine learning-based clinical decision support tool Predict+, and again last spring, releasing a new tool that enables surgeons and hospital staff to upload shoulder CT scans for reconstruction through the web.
“The Exactech Equinoxe shoulder system is...based on a culture of sound research and engineering, and it’s really allowed me to provide patients with a very advanced option for their shoulder,” Dr. Youderian noted in the same online video. “In trying to determine what to use for her [Reese], the ExactechGPS system was a great option because I really wanted to be precise with her. I wanted to make sure that we put the parts exactly where we needed them to be so that she could get back out there and do both her job and get back to her passions.”
Reese is back to her passions these days—both old and new. She’s surfing with her grandsons, scuba diving, taking photographs, and caring for her new rescue dog.
“I decided that I needed something to inspire me to go out and get walking and give me something to take care of. So I went out and got another rescue puppy so that I would continue to be active,” Reese said. “I can actually pick up my [surf]board and put it over my head, which is very exciting [but] the most exciting thing was after about five months, I was able to actually put the big lens on my camera and go back out and start taking pictures again.”
Now, the only sounds Reese hears are those of her camera—click-click-click—and its subjects.
No more SNAP. CRACKLE. POP.
Success stories like Reese’s have become more commonplace in recent years as athletes seek redemption from sports-related injuries and geriatrics seek refuge from age-associated medical conditions (bursitis, osteoarthritis, frozen shoulder). Such motivations have helped the shoulder replacement sector capture the lion’s share of the global upper extremities market, accounting for a 59.5% share in 2022, according to Grand View Research. The market intelligence firm valued the worldwide shoulder replacement market at $400.81 million last year and envisions it expanding 8.2% annually through 2030.
“Like most orthopedic market segments, volumes have shown strong increases, both from the pandemic recovery as well as what appear to be sustainable demand for prolonged activity,” said Kenneth Ross, business development director at Precision Edge Surgical Products LLC, a Sault Sainte Marie, Mich.-based contract manufacturer of fine surgical components, cutting tools, and accessories. “More and more companies are taking on reverse shoulders in their portfolio. I recently spoke to a customer that said they planned to begin internal development on their first total shoulder product line, with the expectation of completion in approximately four years. So the commitment is there.”
It’s there in a big way, too: Most major orthopedic implant manufacturers have made firm commitments to the world’s shoulder replacement patients, offering them numerous alternatives for reconstruction. Exactech, for example, gives new joint hopefuls primary, reverse, and stemless shoulder options, as well as stem preservation, humeral reconstruction prosthesis, and head resurfacing choices (all Equinoxe).
Catalyst OrthoScience, on the other hand, gives patients some flexibility with the Catalyst Stemmed CSR TSA System, a product that can convert to a reverse shoulder as needed. The Naples, Fla.-headquartered firm claims to be the only company to offer anatomically shaped non-spherical heads in both stemmed and stemless solutions.
Flexible options also are available from Smith+Nephew plc. The U.K. firm’s AETOS Shoulder System is intended for both anatomic and reverse total shoulder arthroplasty; the system’s Meta stem is designed for stability with metaphyseal fixation and an inlay collar. Cleared by the U.S. Food and Drug Administration (FDA) in June 2023, the AETOS System requires fewer steps for conversion and fewer instruments for primary anatomic and reverse procedures.
“After using the system for the past several months, I can say the AETOS Shoulder System is a game-changer,” Charles M. Jobin, M.D., an orthopedic surgeon at Columbia University Irving Medical Center, said upon the AETOS’ full commercial launch in February (2024). “With the stability of its Meta Stem, the flexibility the system provides, and streamlined instrumentation, it’s a great solution not only benefitting patients but surgeons alike.”
Another mutually beneficial shoulder fix proffered by Smith+Nephew is the REGENETEN Bioinductive Implant, a collagen-based material that stimulates the body’s natural healing process to repair rotator cuff tears. Roughly the size of a postage stamp, the implant is made from highly purified bovine Achilles tendon and helps facilitate new tendon-like tissue formation in the affected area.
Recent study data substantiate REGENETEN’s efficacy: One-year trial results published in December 2023 suggest that medium and large full-thickness rotator cuff tears repaired and augmented with the REGENETEN implant produced better tendon healing compared with the standard of care. The results showed a significantly lower re-tear rate (8.3% REGENETEN vs. 25.8% for standard of care), a three-times lower re-tear risk, and no difference in the number of serious or minor complications.
In the race to market for robotic-assisted shoulder surgery. Zimmer Biomet Holdings Inc. crossed the finish line first, receiving FDA 510(k) clearance in late February for the ROSA Shoulder System.
Billed as the world’s first robotic-assisted surgical system for shoulder replacement, ROSA Shoulder is the fourth application in the orthopedic behemoth’s robotics portfolio, which includes ROSA Knee System for total knee arthroplasty and ROSA Hip System for total hip replacement.
ROSA Shoulder enables surgeons to perform total shoulder replacements using anatomic or reverse techniques, and improve implant placement accuracy. It is one of the only systems that reproduces humeral head resectioning and eases the insertion of instruments into incisions by requiring no pin in the glenoid’s center during procedures. Like all Zimmer Biomet robotics applications, ROSA Shoulder is designed to support data-informed physician decision-making based on patients’ unique anatomies.
Pre-operatively, ROSA Shoulder integrates with the company’s newly-released Signature ONE Surgical Planning System 2.0, which uses a 3D image-based approach to visualization, surgical planning, and patient-specific guide creation. During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute, and validate personalized plans for glenoid and humeral placement.
ROSA Shoulder will be commercially available in the United States in the second half of this year, and will work with the mymobility Digital Care Management Platform to bolster the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.
“ROSA Shoulder is just the first step in demonstrating what innovation can bring to the extremity market,” noted Nnamdi Njoku, president of Sports Medicine, Surgical, Upper Extremities & Restorative Therapies at Zimmer Biomet. “As digital tools continue to evolve in the extremity space, emerging digital solutions like AI, patient-specific implants, orthobiologics, and increasing surgical robots in ASCs will create new opportunities for preparing surgeons for patient-specific surgeries while improving access to high-quality care for patients, uniformly helping all surgery players in the long run.”
“We are seeing a need in the market for robotic solutions providing real-time insights and feedback in the theater and an increase in interest in solutions proven to optimize outcomes and improve the standard of care,” he continued. “We are currently looking at an extremities landscape where every major player is either developing or has developed their own robotic platform for orthopedic extremities surgery, which will improve the insights surgeons receive throughout the procedure. Thanks to expanding technologies like robotics, navigation, and MR [mixed reality] solutions, patients will eventually have more options to receive the highest quality care possible, which could fundamentally disrupt the market depending on how key stakeholders integrate top-of-industry insights into their solutions.”
That integration thus far has spawned advancements in customized implants, minimally invasive surgical (MIS) techniques, pre-operative planning/surgical navigation software, and sterile procedure kits.
Lewisville, Texas-based Orthofix Medical Inc. has taken the lead in the latter category, expanding its sterile kit lineup in recent years with the latest additions—the Galaxy Fixation Gemini and CalcFix Plus Calcaneal Minifixator systems—entering the market last year.
The Gemini system—the newest Galaxy product family member—is offered in several sterile procedure kit configurations as a quick off-the-shelf solution for treating trauma-related lower and upper limb fractures. Specifically, the Galaxy Gemini ankle kit is marketed as the only pin-to-bar system with specific clamps available in a sterile kit configuration; Orthofix claims the design gives surgeons more efficient lower extremity trauma solutions during time-sensitive circumstances. The ankle kit features a double multi-screw clamp to facilitate the rapid insertion of tibial half-pins and is complemented by the foot support and first metatarsal sterile kits for a more robust construct.
The CalcFix Plus Calcaneal Minifixator System is an updated version of the original CalcFix Fixator device, which treats calcaneal fractures using a more minimally invasive external fixation approach compared with internal fixation. The CalcFix Plus includes design upgrades that reduce the required number of operative steps.
“Continued healthcare cost pressures and preserving sterility in the OR are strong market drivers, leading to more companies offering sterile packaged procedural solutions,” Kim Elting, Orthofix Global Orthopedics president, told ODT. “While becoming a requirement in Europe, there is also a trend in the United States for sterile procedure kits, particularly in trauma settings where time is critical and relying on instrument trays to be processed can create delays and compromise the patient’s surgery. Because of these factors, we are continuing to invest in sterile kit offerings, building on our already industry-leading portfolio of single-use sterile pack solutions, with over 50 different configurations now available worldwide.”
Paragon 28 Inc. followed Orthofix’s lead earlier this year, bolstering its flatfoot, bunion/forefoot, and hallux valgus offerings through minimally invasive solutions.
In late January, the Englewood, Colo.-based company launched the Mister Tendon System, an instrument that enables surgeons to perform a distal cut of the flexor hallucis longus or flexor digitorum longus tendon through a minimally invasive incision, and harvest enough tendon for transfer procedures. Besides the harvester, the Mister Tendon system features an accessory dilator instrument for bluntly dissecting soft tissue, which enhances harvester access without causing additional damage. Using the Mister Tendon system in a minimally invasive approach reportedly can help improve healing and facilitate recovery in flatfoot reconstruction.
Four days after releasing the Mister Tendon System, Paragon 28 debuted the FJ2000 Power Console and Burr System, a tool developed for various minimally invasive, open foot and ankle procedures.
The FJ2000 Power Console and Burr System allows for quick and efficient setup at the start of each procedure. The system has three pre-set options, including a low speed, high torque setting for reducing thermal necrosis during bone and joint preparation, and preserving healthy bone healing.
The FJ2000’s single-use handpieces and selection of burrs and instruments are housed in a sterile packed kit. As a single-use option, the FJ2000 allows surgeons to be more flexible and efficient; it also can help prevent costly delays from the wear and sterilization associated with traditional reusable power systems.
Just two days after the FJ2000’s Jan. 30 introduction, Paragon 28 unveiled the PRECISION MIS Bunion System, which allows surgeons to complete a distal metatarsal osteotomy using a minimally invasive surgical (MIS) technique. The system features an outrigger designed for controlled tri-planar correction including metatarsal head translation and derotation, and distal metatarsal articular angle adjustment. The system also includes instruments to facilitate a freehand technique and cannulated chamfer screws for fixation that help align the metatarsal head near the first metatarsal cortex. This minimally invasive technique is joint preserving, and screw placement is designed to reduce the chance of soft tissue irritation.
“Minimally invasive surgery is one of the main topics of conversation and it’s featured in a majority of medical education programs,” stated Michael Rankin, vice president of Marketing and Medical Education, Foot & Ankle, at Stryker Corp. “There is currently a small percentage of procedures conducted minimally invasively—about 10 percent—but it’s one of the fastest-growing subsegments in the foot and ankle space. The learning curve for the surgeon is much longer, but minimally invasive techniques can help reduce trauma to the body and get patients back to function quickly. Minimally invasive surgery is really hitting the mainstream now and that 10 percent is going to accelerate in the coming years. We are staying ahead of the game with the PROstep MIS Lapidus system.”
Launched last fall, the PROstep MIS Lapidus is a new internal fixation system intended for treating bunions using an MIS hallux valgus deformity reduction and subsequent first metatarsal cuneiform joint fusion. The new technology features MIS joint preparation, triplanar reduction, and a three-screw construct designed to create a tension band for biomechanical stability.
Benefits of the PROstep MIS Lapidus system include a 2.5% decrease in recurrence compared to open Lapidus procedures; a 9% reduction in non-union rates due to MIS Lapidus joint preparation; a 76% reduction in scar size compared to open bunion correction procedures; and less post-op opioid use compared to open Lapidus procedures.
“The shift towards minimally invasive procedures such as arthroscopy have become increasingly common in extremity surgeries, reducing tissue damage, promoting quicker recovery, and enhancing overall outcomes,” said Mike Couch, business development manager at Precision Medical Technologies, an ISO 13485:2003-certified contract manufacturer of orthopedic implants and instruments headquartered in Warsaw, Ind. “Advances in 3D printing technology allow for the creation of patient-specific implants tailored to individual anatomy, improving the fit and function of implants. This has led to less off-label use of products in the operating room and better patient outcomes.”
Artificial intelligence (AI) technology is fostering better patient outcomes too. Exactech’s Predict+, for instance, uses machine learning to predict individual patient outcomes after shoulder replacement surgery to augment surgeons’ decision-making. The software is designed to better inform physicians about expected achievable outcomes after shoulder arthroplasty, based on the clinical experience documented within the world’s largest single shoulder prosthesis outcomes database—consisting of more than 10,000 patients.
Exactech also is conducting several new studies that are using machine learning to analyze CT image-based muscle features to measure muscle size, shape, and quality. The measurements will be used to improve the accuracy of shoulder arthroplasty outcomes predictions.
“Machine learning algorithms can analyze data and optimize prosthetic settings, ensuring a better fit, improved comfort, and enhanced functionality for individual users,” said Dario Renggli, business development manager at high-precision drive systems developer maxon group.
Zimmer Biomet has incorporated AI into the OR to help optimize surgical workflows and procedural efficiencies. Its intelligent, integrated operating room—Omni Suite—automates manual tasks and streamlines unnecessary technology and redundant hardware. The AI feature uses cameras to automatically recognize and timestamp key OR workflow milestones, including patient entry and exit, door count, anesthesia start/stop, surgery, and cleaning. Surgical teams are guided through a process to help optimize OR workflow based on real-time access to workflow metrics.
DePuy Synthes, meanwhile, is leveraging AI to help improve bony deformities in the foot and ankle.
“We are harnessing the power of AI within the elective foot and ankle space and are currently in a limited launch of VirtuGuide—a differentiated, pre-operative Patient-Matched Lapidus correction system powered by predictive AI software,” explained Oray Boston Jr., worldwide president, DePuy Synthes Trauma, Extremities, Craniomaxillofacial, Animal Health, and Sports. “Our VirtuGuide AI Patient-Matched Platform provides physicians with an automated patient analysis to treat bony deformities of the foot and ankle. The AI software outputs the single deformity correction instrument needed to treat that specific patient, which allows for intra-operative simplicity, fewer instruments, and reduced surgery time. This is truly an exciting advancement for surgeons and their patients.”
AI also is helping generate excitement among surgeons and patients well before the latter group even enters the operating room. Pre-operative planning/navigation software has now become fairly standard with most extremity solutions due to its proficiency in implant placement accuracy and procedural precision.
Earlier this year, Stryker expanded its Prophecy Surgical Planning System to the entire foot, providing clinicians with a more integrated approach and complete view of the foot around the ankle.
Orthofix’s OrthoNext platform system overlays Orthofix product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template.The OrthoNext software enables surgeons to accurately plan an osteotomy position and visualize an implant in relation to the anatomy. It also streamlines the selection of a precise device size and enables optimal positioning for the patient’s body before the surgical procedure.
“AI is contributing to training simulations that improve procedure quality and efficiencies,” stated Brad Womble, senior director of Strategy and Business Development at Cirtec, a full-service outsource partner.
Such improvements are critical as orthopedic procedures increasingly shift from the hospital to ambulatory surgical centers (ASCs). Numerous factors are contributing to this shift, including advances in technology, patient and physician preference, and regulatory and reimbursement changes.
“Shifting procedures towards ambulatory surgical centers is rapidly redefining the treatment site of care landscape in extremities surgery, and is continuing to reshape how medtech companies introduce solutions to the market,” Njoku said. “With the growing demand for efficiency and better patient outcomes, medtech companies are beginning to see themselves as key partners for ASCs and are presenting patient-focused integrated technology solutions. Ultimately, with the goal to accelerate growth in the ASC space. These solutions, like robotics, are also emerging at a time when patients are returning to the surgery room post-pandemic for elective extremities procedures at high volumes, meaning the need for customized solutions and surgical robotics assistants has never been higher. The time is perfect for companies to introduce their enabling technology solutions to the extremities market and to address these demands.”