J&J's DePuy Synthes scores FDA clearance in reverse shoulder joint replacements

The FDA has granted a new clearance to DePuy Synthes’ total shoulder replacement implant, opening it up to more joint procedures. 

The Inhance system previously received a green light for anatomic arthroplasty—where the implant mimics the shoulder’s natural ball-and-socket structure, with the rounded top of the upper arm bone fitting within the opening made by the shoulder blade.

Now, the Johnson & Johnson orthopedics division can offer the device for what is called reverse shoulder arthroplasty, where the new joint works in the opposite direction: the shoulder blade’s socket is replaced with a metal ball, and the top of the humerus holds the matching plastic socket.

Reverse shoulder procedures made up 70% of all total shoulder replacements in the U.S. in 2020, with the approach typically chosen when arthritis is present in the shoulder joint and the rotator cuff tendons are weakened, according to the company.

In addition, DePuy Synthes said the agency’s clearance this week allows surgeons to switch between the anatomical or reverse method as needed during a procedure, should they discover severe bone loss within the shoulder blade or inadequate strength in the arm bone.

The Inhance shoulder was built with an eye toward the increasing shift of joint replacement procedures from larger hospitals to outpatient and ambulatory surgical centers, which has placed a premium on the ability to quickly process a higher volume of cases.

That includes methods to cut down procedure times, such as a concentric drilling bit that creates multiple holes in the shoulder bone with a single, less-invasive surgical step that is compatible with any size implant.

Launched last year to compete with shoulder replacement offerings from Zimmer Biomet and Stryker, the Inhance system was acquired through DePuy’s multiyear agreement with the Warsaw, Indiana-based Ignite Orthopedics.