Ensemble Orthopedics gains FDA clearance for hand implant

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.

Original Article: (https://www.massdevice.com/ensemble-orthopedics-gains-fda-clearance-for-hand-implant/)