FDA 510(k) Recap: First Orthopedic Clearances
This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six...
Jan 25 2021,
Products
FDA 510(k) Recap: 2020 Highlights Across the Market Segments
Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap...
Dec 15 2020,
First 510(k)s for Companies in Joint Replacement, Spine, Trauma, SportsMed and Obio
This month’s recap rounds up many companies new on our radar, helmed by people who've known the industry for a...
Nov 17 2020,
Trauma Technologies Emerge to Meet the Needs of Patient Anatomy
A burgeoning set of small orthopedic implant companies is developing devices designed to anticipate and suit individual patients’ unique anatomy....
Nov 16 2020,
FDA 510(k) Recap: Companies Gain Trauma Device Clearances
As the Orthopedic Trauma Association holds its Annual Meeting this week, we look at companies that seek to make a...
Oct 20 2020,
The Future of Instruments is Disposable, Durable and Smarter
We spoke with instrument suppliers to find out what is top of mind for their customers and learn how they’re...
Sep 30 2020,
FDA 510(k) Recap: First Clearances in 2020
We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside...
Sep 22 2020,
10 Spine Companies Receive Their First FDA 510(k)
Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but...
Sep 18 2020,
FDA 510(k) Recap: Total Ankle Clearances in 2020
The total ankle market is attractive for current and new players. We review four total ankle devices, three from new...
Aug 24 2020,
Exactech Transitions Stemless Shoulder to 3D Laser Printing
The bone-conserving anatomic total shoulder is now being manufactured using direct metal printing with high precision lasers to create its...
Jul 23 2020,
FDA 510(k) Recap: Spine Company Clearances
Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list...
Jul 20 2020,
Engage Surgical Gains FDA Clearance for Cementless Partial Knee
This is reported to be the only cementless partial knee system available in the U.S. It is cleared for both...
Jul 08 2020,
IlluminOss Gains FDA Clearance for Treatment of Pelvic, Clavicle and Small-Bone Fractures
The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market....
Jul 08 2020,
FDA 510(k) Recap: Lesser-Known Companies and First Orthopedic Clearances
FDA cleared 40 orthopedic products in May. We highlight four companies that may be new names to you as well...
Jun 22 2020,
Smith+Nephew Launches INTELLIO Connected Tower for Sports Medicine
The new INTELLIO Connected Tower Solution wirelessly connects and remotely controls multiple Sports Medicine systems from outside the sterile field....
Jun 22 2020,