Extremity Medical, LLC (Parsippany, NJ) announced today that it has received FDA clearance for the TrapEZX Anatomic Trapezium Prosthesis. The company also announced that it had received CE Mark for the product and is initiating limited release in selected centers in U.S. and Europe.
The TrapEZX Prosthesis is the first completely anatomic trapezium bone replacement available in the world. The device is intended to treat degenerative and post traumatic disabilities of the thumb basal joint. The implant design and surgical technique were developed in close collaboration with Amy Ladd, MD, Professor & Chief, Robert A. Chase Hand & Upper Extremity Limb Center, Stanford University Medical School, Arnold Peter Weiss, MD, Professor of Orthopedics, Alpert Medical School of Brown University, and John Faillace, MD, FAAOS, Hand and Orthopedic Surgery, Waco, Texas. The biomechanics of the device were developed in collaboration with Professor J.J. Trey Crisco, Ph.D., Director Bioengineering Laboratory, Department of Orthopaedics, Alpert Medical School of Brown University.
The TrapEZX Trapezium Replacement is the first of its kind that is anatomic and incorporates a window designed to offer the potential of hematoma encapsulation for long term stability. Ladd commented, “Extremity Medical has delivered the first anatomic trapezium prosthesis which restores the natural architecture and biomechanics of the basal thumb joint.” Weiss added, “The simple, single piece design allows for a rapid procedure, requiring only trapeziectomy using standard technique, provisional fixation with a suture anchor and standard capsular closure. This device gives the Hand Surgeon a new option with the potential to restore grip and pinch strength following debilitating osteoarthritis of the CMC joint.”
The TrapEZX System is the fourth product released by Extremity Medical in 2009. Extremity Medical is committed to delivering solutions to the most challenging conditions faced by surgeons treating the distal extremities, through collaboration and based on the ideas and research of key opinion leaders from around the world.
About Extremity Medical, LLC
Extremity Medical, LLC is an orthopedic device company specializing in the development of next generation products. Extremity Medical is targeting the challenging requirements of surgeons specific to treating the distal extremities, including the hand, wrist, foot, and ankle, with a focus on identifying unmet needs and developing unique solutions for fusion, fixation and motion preserving systems for both upper and lower extremities.