Extremity Medical, LLC announces that it has received 510(k) clearance from the FDA to market IO FiX TRIO™ Calcaneal Osteotomy Device. This plate is an addition to the IO FiX™ fixation platform and has been cleared for fixation of osteotomies of the calcaneus. The IO FiX TRIO™ offers a novel approach to plate fixation for calcaneal osteotomy. The intent of this design was focused on delivering a best-in-class plate which would provide [...]

Extremity Medical, LLC announced that the Express Staple System™ has received 510(k) clearance. The Express Staple System™ is a compressive osteosynthesis staple indicated for the fixation of hand and foot bone fragments, osteotomy and joint arthrodesis. Matt Lyons, Chairman, and CEO of Extremity Medical commented,“The Express Staple System™ provides a staple solution for the extremity surgeon which pairs a high quality superelastic nitinol staple with what Extremity Medical feels is a best [...]

Early indications following the first fifty implanted HammerFiX devices show successful outcomes. “My early experience with the HammerFiX system has shown it to be simple and easy to work with—intuitive steps. I am confident with the positioning and stable fixation provided by the implant; the alignment looks great. At the 4-week follow-up visit, there was no pain, minimal swelling and X-rays showed stable apposition,” stated Jeffrey Brodie, M.D. HammerFiX is the first [...]

Extremity Medical, LLC announced that it has received 510(k) clearance for the HammerFiX™. The HammerFIX™ device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Jamy Gannoe, President and Co-Founder of Extremity Medical commented,“The HammerFiX™ implant is the first cannulated hammertoe device made of the non-resorbable polymer PEEK in the U.S. PEEK has a modulus of elasticity (stiffness) [...]

Extremity Medical, LLC announced that it has received 510(k) clearance for Apex IP Fusion System. The Apex System is used for intramedullary fixation of the interphalangeal joints in the hand. This unique system is based on the company’s proprietary intraosseous fixation platform and provides an easy technique, reproducible fixed angles, stable fixation, in a minimal profile device. Jamy Gannoe, CEO and Co-Founder of Extremity Medical commented "Apex delivers interphalangeal joint fusions to [...]

Extremity Medical announces the first KinematX TM Midcarpal Joint Hemiarthroplasty procedure was recently performed at the Spire Wellesley Hospital in Southend, England by Consultant Orthopaedic Surgeon Greg Packer, FRCS Ed, FRCS Ed Orthopaedics. The KinematX device, invented and patented by Scott Wolfe, M.D., hand and upper extremity surgeon at Hospital for Special Surgery, NewYork City, and Joseph J. “Trey” Crisco, Ph.D., Brown University and Rhode Island Hospital, Providence, R.I., is the first [...]

Extremity Medical, LLC Receives FDA Approval on the IOFiX Foot and Ankle System. Extremity Medical, LLC (Parsippany, NJ) announced today that it has received 510K clearance from the FDA on the IOFiX Intraosseous Fixation System for performing a variety of procedures in the foot and ankle. The company also announced that the CE Mark has been received for this product. This comprehensive system provides a completely new method for delivering compression and [...]

Extremity Medical announces that it has received 510K clearance from the FDA for the company’s IOFiX MCP Intraosseous Fixation System. Extremity Medical, LLC (Parsippany, NJ) announced today that it has received 510K clearance from the FDA for the company’s IOFiX MCP Intraosseous Fixation System for arthrodesis of the Metacarpal Phalangeal joints in the hand. The company also announced that it had received CE Mark for the product and was commencing limited release [...]

Extremity Medical, LLC receives ISO 13485 certification for its Quality Management System Extremity Medical, LLC, an orthopedic device company, announced today that the company has recently received the internationally recognized ISO 13485:2003  certification for their Quality Management System. This major milestone certifies that the company is in compliance with the stringent requirements of ISO 13485:2003 for the design, development and manufacture of hand, wrist, foot and ankle fixation and arthroplasty implants. The [...]