Dr. Armodios Hatzidakis of Western Orthopaedics, PC, Denver Surgery Center and Rose Medical Center, completed the implant. It marks the first such implant since Stryker received FDA de novo clearance in late 2022. The company first completed an investigational device exemption (IDE) study with the FDA.
“Historically, joint replacement surgery for younger patients with severe shoulder arthritis has been challenging, with a high early failure risk due to socket component loosening,” said Dr. Hatzidakis, the primary investigator for the IDE. “I’m very pleased with the results my patients in the clinical trial have had with Stryker’s Tornier pyrocarbon humeral head, including those with up to seven years of follow-up. It’s encouraging to have an alternative for patients without the risk of socket component loosening.”
Pyrocarbon features surface properties more similar to bone than traditional orthopedic metallic bearing surfaces. The advanced bearing material has been utilized in orthopedics since the early 1990s, Stryker said. Its uses extended to shoulder cases in 2013.
Stryker said it’s the first company to offer an FDA-cleared pyrocarbon implant for shoulder hemiarthroplasty in the U.S.
“As a global leader in shoulder arthroplasty, we are excited to bring this technology to the United States,” said Tim Lanier, VP and GM, upper extremities, Stryker. “Dr. Hatzidakis’ first clinical usage of the pyrocarbon humeral head for shoulder hemiarthroplasty is another milestone demonstrating our drive to provide new options for shoulder surgeons and their patients and make healthcare better.”
