The implant earned de novo clearance in late 2022 following an investigational device exemption study with the FDA, according to a March 30 press release.
Pyrocarbon has been used in orthopedics since the 1990s and was first used in shoulder applications in 2013, but Stryker is the first U.S. company to offer an FDA-cleared pyrocarbon implant for shoulder hemiarthroplasty.
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