Extremity Medical in the Press
Announcing 510(k) clearance for the IO FiX TRIO™ Calcaneal Osteotomy Device
March 4, 2015
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 [...]
Announces 510(k) Clearance for its Express Staple System™
December 19, 2014
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 [...]
Announces 50th Implantation of FDA-cleared HammerFiX Device
May 18, 2014
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 [...]
Announces 510(k) Clearance its HammerFiX™ IP Fusion Device
April 2, 2014
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 [...]
Announcing 510(k) Clearance for APEX IP Fusion Device™
April 11, 2013
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 [...]
Extremity Medical, LLC and Hospital for Special Surgery announce world’s first midcarpal based hemi wrist arthroplasty
March 30, 2011
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, [...]
Announcing 510(k) Clearance on the IOFiX Foot and Ankle System
November 17, 2010
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 [...]
Announcing 510K clearance for IOFiX MCP Intraosseous Fixation System
May 7, 2010
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 [...]
ISO 13485 certification for its Quality Management System
May 15, 2009
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 [...]