Ensemble Orthopedics Inc receives 510(k) clearance for carpometacarpal joint implant
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Ensemble Orthopedics Inc. announced it has received 510(k) clearance for its Ensemble CMC Implant for treatment of early stage osteoarthritis of the carpometacarpal joint.
According to a company press release, the implant is designed with a saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones, and the interpositional implant allows for normal, pain-free motion. The release noted the device is inserted with minimal disruption to the joint capsule and preserves critical stabilizing soft tissues and offers the potential for faster rehabilitation. Constructed using On-X PyroCarbon, a proprietary form of pyrolytic carbon produced by On-X Life Technologies Inc., the implant is available in three sizes and utilizes a simple instrument set, according to the release.
“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,” Thomas Trumble, MD, chief medical officer of Ensemble Orthopedics, said in the 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.”
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