Stryker today announced that Armodios M. Hatzidakis, MD, FAAOS, Western Orthopaedics, PC, Denver Surgery Center and Rose Medical Center, has successfully completed the first case in the United States, since the De Novo clearance, using the Tornier Pyrocarbon Humeral Head. Stryker’s De Novo request was granted in late 2022 after completing 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 is an advanced bearing material that has surface properties more similar to bone than traditional orthopedic metallic bearing surfaces. It has been utilized internationally for a variety of orthopedic procedures since the early 1990s and in shoulder cases since 2013. Stryker is 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, vice president and general manager, 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.”