Nexa Orthopedics, Granted FDA Clearance to Market Pyrolytic Carbon Implant

Filed in archive Treatment on May 24, 2006

The technology leader in products for reconstructive surgery of the extremities, Nexa Orthopedics, Inc. has recently received 510(k) clearance from the USFDA to market its pyrolytic carbon Carpometacarpal Implant (CMI).

"Pyrolytic carbon has been the gold standard in heart valves for more than 35 years due to its biocompatibility, surface characteristics and wear resistance," said Chris Harber, Nexa's Vice President, Marketing and US Sales.

"These properties make pyrolytic carbon an excellent material for hemi and interpositional arthroplasty applications. Nexa is the only company that designs, manufactures and distributes pyrolytic carbon orthopedic implants in the world, and American extremities surgeons can expect expanded access to pyrolytic carbon implants in 2006 and beyond."

The CMI was designed to relieve basal thumb joint pain associated with arthritis while improving the thumb's range of motion and biomechanical function, and is intended to replace the proximal end of the first metacarpal for treatment of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation or bone loss.

CMI will be officially launched in the United States in September 2006 at the American Society for Surgery of the Hand conference in Washington, DC.

Read the complete Nexa press release.