Ensemble Orthopedics recently announced said it received FDA 510(k) clearance for its Ensemble CMC Implant.
The implant is designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure.
Ensemble CMC features a saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones with an interposition implant. It allows for normal, pain-free motion and combines minimal joint resection with a stable design.
The device is inserted into the joint capsule to stabilize soft tissues for faster rehabilitation. It is available in three sizes and uses a simple instrument set.
“In my experience with CMC implants, the unique design of the Ensemble CMC distributes loads across joint surfaces providing superior implant stability and resistance subluxation/dislocation throughout its range of motion,” chief medical officer Thomas Trumble said in a news release. “Because the Ensemble CMC interpositional implant is stemless, it can be inserted through a smaller incision with less disruption than what is required for other implants, thereby preserving all major stabilizing soft tissue structures of the thumb.”
Ensemble CMC is made using On-X PyroCarbon, which is a high strength, low modulus material that has been shown to offer superior wear resistance when bearing against bone than either metal or ceramic.