Exactech, a developer and producer of orthopedic medical devices, has received 510(k) clearance from the FDA to market its Equinoxe Platform Fracture Stem, the latest addition to its shoulder arthroplasty line.
The Equinoxe Platform Fracture Stem is designed to relieve pain and restore function in shoulder patients with acute fractures of the proximal humerus or a deficient, irreparable rotator cuff. It is compatible with Exactech’s Equinoxe Reverse shoulder components giving orthopaedic surgeons the intra-operative flexibility to decide whether to perform a hemiarthroplasty or a reverse total shoulder.
Exactech has been conducting clinical evaluations of the shoulder fracture stem this quarter, with market launch targeted for the second half of 2010. According to industry reports, the number of shoulder replacement procedures increased more than 10% to just over 70,000 procedures in 2009. Of these procedures, there has been growth in the use of reverse shoulder prostheses.
Joseph Zuckerman, member of the design team, professor and chairman of the NYU Hospital for Joint Diseases Department of Orthopaedic Surgery, said: “The Equinoxe Platform Fracture Stem is a new addition to Exactech’s shoulder implant product line. It is designed to address some of the latest clinical challenges surgeons face in shoulder arthroplasty.
“The platform system enables surgeons to convert a well-fixed fracture stem to a reverse shoulder implant without the complexity and potential complications of removal of a well-fixed stem.”