Startup gets FDA clearance for pyrocarbon CMC interpositional spacer

Ensemble Orthopedics Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for its Ensemble CMC Implant, which was designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure. Hand osteoarthritis is an extremely common condition that causes pain while limiting function. Current treatment modalities typically start with pharmacological and immobilization approaches for mild cases, progressing to surgical intervention with either joint resection or joint replacement in severe...


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