Rachel Klemovitch, Assistant Editor05.01.24
Popular news items in April included FDA approvals for multiple companies, product releases, and completed surgeries.
Many companies received FDA approvals this past month. Medtronic’s Inceptiv closed-loop, rechargeable spinal cord stimulator (SCS) gained approval for treating chronic pain. Onkos Surgical got approval for its De Novo approval for its antibacterial coating implants.
The 3-D printed PEEK Cranial Implants by 3D Systems also received FDA approval this past month for patient-specific cranial reconstructions. The FDA also approved of Orthobond’s antibacterial surface treatment called Ostaguard.
DePuy launched its TriALTIS Spine System for clinical needs within degenerative, tumor, trauma, and deformity pathologies in the spine. Paragon 28 released its Gappler R3INFORCE extraosseous repair system, for anterior and posterior ankle stability.
Zimmer Biomet completed its first successful surgery of its ROSA Shoulder System by a team at Mayo Clinic in Rochester, MN. Hyalex Orthopedics announced the completion of the first-in-human trials of the Hyalex knee cartilage system.
1. Medtronic's Inceptiv Closed-Loop, Rechargeable Spinal Cord Stimulator Gets FDA Approval
2. FDA Grants De Novo Approval to Onkos Surgical's Antibacterial-Coated Implants
3. DePuy Synthes Releases TriALTIS Spine System
4. Zimmer Biomet Completes First Successful Surgery Using Its ROSA Shoulder System
5. Zimmer Biomet Becomes Medical Device Partner to 3 U.S. Pickleball Organizations
6. ZimVie Closes Sale of its Spine Business
7. 3D Systems Gains FDA Clearance for its 3D-Printed PEEK Cranial Implants
8. First-in-Human Hyalex Knee Cartilage Treatments Completed
9. Orthobond's Antibacterial Surface Treatment OK'ed for Spinal Devices
10. Paragon 28 Launches Grappler R3INFORCE Extraosseous Repair
Many companies received FDA approvals this past month. Medtronic’s Inceptiv closed-loop, rechargeable spinal cord stimulator (SCS) gained approval for treating chronic pain. Onkos Surgical got approval for its De Novo approval for its antibacterial coating implants.
The 3-D printed PEEK Cranial Implants by 3D Systems also received FDA approval this past month for patient-specific cranial reconstructions. The FDA also approved of Orthobond’s antibacterial surface treatment called Ostaguard.
DePuy launched its TriALTIS Spine System for clinical needs within degenerative, tumor, trauma, and deformity pathologies in the spine. Paragon 28 released its Gappler R3INFORCE extraosseous repair system, for anterior and posterior ankle stability.
Zimmer Biomet completed its first successful surgery of its ROSA Shoulder System by a team at Mayo Clinic in Rochester, MN. Hyalex Orthopedics announced the completion of the first-in-human trials of the Hyalex knee cartilage system.
1. Medtronic's Inceptiv Closed-Loop, Rechargeable Spinal Cord Stimulator Gets FDA Approval
2. FDA Grants De Novo Approval to Onkos Surgical's Antibacterial-Coated Implants
3. DePuy Synthes Releases TriALTIS Spine System
4. Zimmer Biomet Completes First Successful Surgery Using Its ROSA Shoulder System
5. Zimmer Biomet Becomes Medical Device Partner to 3 U.S. Pickleball Organizations
6. ZimVie Closes Sale of its Spine Business
7. 3D Systems Gains FDA Clearance for its 3D-Printed PEEK Cranial Implants
8. First-in-Human Hyalex Knee Cartilage Treatments Completed
9. Orthobond's Antibacterial Surface Treatment OK'ed for Spinal Devices
10. Paragon 28 Launches Grappler R3INFORCE Extraosseous Repair