The Orthopedic Design & Technology Web Showcase highlights the web sites of advertisers in this issue. To receive more information on these companies, visit their sites directly.
Accutek Testing Laboratory
For over 20 years, major companies across various industries have turned to Accutek for their product conformance, material identification, and failure analysis needs. Accutek's engineering professionals and full-service testing facility provide the critical knowledge, personalized service and timely delivery of your testing requirements. Accutek now features the MTS Bionix Spine Wear Simulator.
Web: www.accutektesting.com
Avalign Technologies Inc.
A full service provider of complete systems to the medical device community. We have combined the custom/specialty instruments and implant manufacturing of NEMCOMED with the metal/ thermoformed case and tray manufacturing of Advantis Medical to provide single source support for all of your single product or system launch needs. Our complete focus on unmatched quality, on-time delivery and outstanding technical support means you - our customer - will get the right product, on time and on budget.
Web: www.avaligntech.com
Bradshaw Medical
Bradshaw Medical gives you the competitive edge in today’s highly specialized design & development of OEM orthopedic and spinal surgical instruments. We manufacture world-class instruments from the highest quality materials to meet your most demanding requirements. Our team is ready to work closely with your staff in providing solutions to the challenges of today’s highly competitive marketplace. We have the Experience, Vision, and State-of-the-Art R&D and manufacturing capabilities to be able to develop innovative instruments in time for your next critical product launch.
Web: www.bradshaw-medical.com
C5 Medicalwerks
C5 Medical Werks is a leading provider of Implantable Ceramic Components for the following medical market segments:
• Ceramic Orthopaedic Components
• Ceramic Spinal Components
• Ceramic Dental Components
C5 Medical Werks assures quality through a single quality management system certified to ISO 13485 and meeting the FDA 21 CFR 820
Web: www.c5medicalwerks.com
Criterion Instrument
Criterion Instrument, an FDA registered, ISO 9001:2000 certified precision machine shop that supports medical device companies by producing medical instruments, implants and diagnostic instrumentation. We manufacture prototype components for Class II & Class III medical devices. Visit Criterion’s website to view samples of our expertise in CNC Milling, Turning & Swiss Turning.
Donatelle
Donatelle is an FDA compliant, ISO-9001:2000 and ISO-13485:2003 certified supplier with expertise in molding engineering grade thermoplastic and elastomeric materials, micro molding, and liquid silicone injection molding. Our diverse list of capabilities includes: complete design and engineering services, a dedicated R&D and rapid prototyping department, in-house CAD/CAM based tooling design and fabrication, insert molding, overmolding, white room molding, Class 100,000 and 10,000 clean room assembly. In addition, we offer extensive contract manufacturing services that include: assembly, machining, welding, decorating, packaging, and sterilization management.
Web: www.donatelle.net
Edge International
Materials for the forging and machining of orthopedic implants. Specializing in Cobalt-Chrome-Moly bar (low and high Carbon). Immediate delivery from stock. Sizes 0.375" - 2.500" dia. From one bar length to mill quantities. Certified to ASTM, ISO and Major Medical Implant Manufacturers' House specifications. Full technical and metallurgical support.
Web: www.edgeintl.com
Electrolizing Corp of Ohio
MEDCOAT 2000 TM, developed by The Electrolizing Corp. of OHIO, significantly improves the appearance and service life of medical devices, increases resistance to wear and prevents corrosion. Ti-Med Titanium Anodizing is a safe process that colors without dyes and can be used on medical parts, components and instruments. ISO 9001:2000. Biocompatible per ISO 10993. Visit www.electrohio.com or www.medcoat2000.com.
Web: www.electrohio.com
Fischer Connectors
Sleek, rugged, and reliable, Fischer connectors are engineered to provide the highest level of performance in even the most harsh or demanding applications. Choose from high-performance metal or plastic shells in a wide range of styles, sizes, and contact configurations, available sealed to IP68. See the company’s L.U.C.TM limited-use connector system.
Gibraltar Labs
This 35-year old company has an international reputation for quality services and testing in Bacteriology, Mycology, Virology, Chemistry and Packaging. The company, headed by Daniel L. Prince, Ph.D., operates laboratories in Fairfield, NJ. Gibraltar Laboratories performs rapid and accurate testing services under cGMP at reasonable prices in a timely manner. Further, the company is unique in that all departments are headed by Ph.D. or master’s level scientists with prior experience in industry or academia, it has a research policy that has resulted in over 60 papers or publications in the archive or trade literature it maintains contacts with regulatory or compendial personnel in FDA, EPA and USP.
Web: www.gibraltarlabsinc.com
Judson A. Smith Company
Judson A. Smith Company manufactures small diameter metal tubular parts and machined components to customers specifications. Capabilities include Swiss screw machine parts, CNC milling and turning, laser cutting/welding, notching, bending, expanding and more. The company is ISO 9001:2000 certified.
Web: www.judsonsmith.com
LaVezzi Precision Inc.
LaVezzi Precision, Inc., is an ISO certified contract manufacturer specializing in complex, burr-free, high precision machining of device components and implants with tolerances to .000040". Multi-faceted parts are machined with the latest technology, including 5- and 9-axis Swiss CNCs, CNC turning with C and Y axis, 5-axis CNC milling capability, full C-axis CNC grinding, and Agathon centerless grinder and Rollomatic grinder for cutting instruments such as drills and burrs. Parts are delivered exact to requirements on the date required.
Mack Molding
Mack Molding Co. provides design through FDA-approved manufacturing services to the medical, surgical, orthopedic, diagnostic and drug delivery industries. With 87 years of plastics expertise, the company integrates product development, custom injection molding, sheet metal fabrication, and full product assembly in ISO 9001 and ISO 13485 environments. Product development resources include design, prototyping and extensive engineering services.
Web: www.mack.com
Medicraft, Inc.
For nearly 15 years Medicraft Inc. has been a leading developer and manufacturer of implant/instrumentation delivery systems for the medical industry. Our ISO9001 certified facility produces everything from standard case and tray products to custom engineered specialty items. Medicraft works exclusively for the medical device industry. Our production methods are designed and tooled solely for that purpose. Our mission is to provide the ideal product solutions to fit our clients needs precisely, then manufacture to the highest standards in the most cost-effective manner.
Metal Craft Machining & Engineering, Inc.
We are a State of the art contract manufacturer serving the Medical Device Industry in the manufacturing of instruments and implants; specializing in close tolerance precision manufacturing including Design, Prototype, Short and Long Run Production, Multi-axis (3,4,5) Milling, 7-10 axis Swiss turning/milling, 7- axis grinding, Wire EDM, Gundrilling, Laser Etch, Passivation, Value Added Assembly and non sterile packaging & labeling. ISO Registered and cGMP compliant.
Miltronics & Skye
Miltronics & Skye is a contract manufacturer servicing the medical device market. Miltronics has the manufacturing expertise in place to deliver an exceptionally high quality product within extremely tight time parameters. We have built our reputation on manufacturing complex geometrical components including cervical and small bone fixation plates, polyaxial and monoaxial bone screws, hooks and rod connectors. We employ more than 100 of the nation’s most skilled engineers and manufacturing specialists. In addition to our worldclass engineering support, Miltronics also has state-of-the-art manufacturing technology including the latest CC Swiss turning equipment and highspeed milling equipment.
Miraclean Ultrasonics
Miraclean is a leading manufacturer of precision cleaning systems for medical devices and implants. Systems include ultrasonic cleaning lines, passivation lines, electropolish lines, and automated liquid penetrant inspection lines. Miraclean specializes in process development, process automation, and custom fixturing to meet and maintain exacting cleanliness requirements.
MTS Systems Corporation
Bionix® Orthopaedic Testing Solutions Biomedical researchers rely on MTS testing technology and expertise to optimize critical testing processes and ensure regulatory compliance. MTS Bionix solutions are deployed worldwide for orthopaedic applications ranging from knee to hip to spine. Uses include wear simulation, biomaterial and fixation device testing, joint and structures characterization, and the study of surgical techniques.
NAMSA
For over 40 years, NAMSA has been the global leader specializing in the safety evaluation of medical devices. Our expertise and experience enables us to provide guidance and continued support through regulatory submission, defense, and approval. Our goal is to accelerate the successful launch of our clients’ products into markets worldwide.
Oberg Industries
Oberg Industries proudly announces a major redesign of our corporate website, www.oberg.com. The fresh new look features case studies of how Oberg successfully develops manufactruing solutions that greatly benefit out customers. With enhanced content, improved functionality and navigation organized by markets, the new site is designed to help visitors quickly and easily find relevant information.
Web: www.oberg.com
Omni Components
Omni is an ISO 9001:2000 & 13485:2003 manufacturer of precision machining services and engineered solutions to the medical industry. All CNC machining: Swiss to 1 1/4 in. diameter, mill/turn lathe to 2 3/4 in. diameter, milling, prototyping, laser marking, EDM & assembly services. Turnkey support for all value added features for a complete part.
Orchid Orthopedic Solutions
Orchid Orthopedic Solutions is built on the strength of its team of seven contract manufacturers. With a combined 100 years of expertise in the medical industry, Orchid delivers an array of comprehensive contract manufacturing services, including design capabilities and dependable on-time delivery of quality medical implants, instruments and more.
Paragon Medical
Paragon Medical is a single source turnkey supplier of custom and standard surgical instrumentation, implantable components and cases & trays to the worldwide medical device marketplace, with a concentration in hip, knee, spine, trauma, and sports medicine disciplines. Office and production facilities are located throughout the US and in Europe.
Web: www.paragonmedical.com
Phillips Precision, Inc.
For almost 40 years, Phillips Precision Inc., an ISO 13485:2003 certified facility, has been a leading supplier and manufacturer of advanced orthopaedic implants, instrumentation and sterilization delivery systems. By combining the world's most advanced manufacturing equipment, technology and software with the most skilled and experienced personnel in the industry, we are able to provide to our customers a various array of the most sophisticated products with exceptional quality, price and service.
Polymer Technology Group
The Polymer Technology Group ("PTG") is the technology leader in bringing new specialty chemicals and polymer-based solutions to critical material intensive applications in medical and related fields. PTG's combined experience in biomaterials and medical devices offers your company support in material design and selection, synthesis and characterization, prototype fabrication and manufacturing of components and medical devices.
Web: www.polymertech.com/main.html
Precimed, Inc.
Precimed, a division of Greatbatch (NYSE: GB) is a manufacturer and developer of orthopedic products. ISO 9001:2000 and 13485:2003 certified; CE mark for standard products and FDA registered. Manufacturing sites include full product surface finishing capabilities, automated product flow controls and CAD/CAM interface. Manufacturing facilities are located throughout Switzerland and the US.
Web: www.precimed.com
Precision Edge Surgical Products Co. LLC
When you need a reputable contract manufacturer, our highly skilled workforce will assist you in meeting your delivery, quality and pricing objectives. Our new and improved manufacturing processes supply precision parts with minimal lead times. Let us quote your next drill, bur, instrument, plate, or blade order.
Web: www.precisionedge.com
Precision Medical Products
Precision Medical Products, Inc., the preferred choice for medical device outsourcing, represents over 50 years of experience in manufacturing, assembly and packaging of medical devices incorporating a variety of metalworking and plastic molding technologies for the leading pharmaceutical and medical device suppliers worldwide. For more information visit our website www.pmp.net.
Precision Punch
Our web site offers customers a convenient, easy-to-understand resource for our products and services. It is formatted to compliment our product catalog listings. Each product is supported by technical specifications, engineering drawings and available options. You can browse through our product offerings, review our new technical reference section and learn more about Precision Punch.
Web: www.ppunch.com
Sayan Surgical Instruments Ltd.
Sayan is an instrument manufacturing company with profession in orthopedics.As well as designing and producing individual orthopedic instruments, our main focus is designing complete set of instruments in accordance with the related implant and manufacture the custom designed set as fully finished. Sayan also provides post-marketing service to repair and revise the instrument sets in use at the hospitals.
Web: www.sayan.com.tr
Specialized Medical Devices
Implants – Instruments – Class 10,000 Clean Room Packaging. SMD specializes in complete spinal implant systems, small bone implant systems as well as custom orthopedic instrumentation. SMD is a full service manufacturer from prototype runs to full production. SMD’s expansive in-house capabilities include: Ultra precise CNC-Swiss screw machining, 5-axis vertical milling, wire EDM, titanium anodization, a validated implant cleaning process, heat treating, laser marking, anodizing, electropolishing and passivation. Materials: titanium, stainless steel, cobalt chrome and Peek. FDA registered, ISO 13485:2003 certified.
Web: www.specializedmedical.com
Supra Alloys, Inc.
Supra Alloys is a premiere TITANIUM Supplier to the Orthopaedic Industry. Supra Alloys has over 4 decades of experience and can routinely provide Technical assistance with TITANIUM Products and Applications. Supra Alloys carries an extensive TITANIUM inventory, including product forms such as PLATE, SHEET, STRIP, FOIL, BILLET, BAR, and WIRE. Our TITANIUM Inventory consists of Various Grades of TITANIUM, Commercially Pure and Alloy. All our TITANIUM Inventory is fully certifiable to the standard Orthopedic Specifications (ASTM F-136, F1472, F67 & ISO 5832).
Web: www.supraalloys.com
Symmetry Medical, Inc.
Symmetry Medical (NYSE:SMA) is a leading provider of implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce these products for companies in the arthroscopy, dental, laparoscopy, osteobiologic, endoscopy and other segments of the medical device market, as well as provide specialized products and services to the aerospace market.
Web: www.symmetrymedical.com
