Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, has announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company’s Equinoxe Platform Fracture Stem, the latest addition to the company’s shoulder arthroplasty line.
In a release, the Company noted that 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.
Joseph D. Zuckerman, MD, member of the design team and professor and chairman of the NYU Hospital for Joint Diseases Department of Orthopaedic Surgery, said, “The Equinoxe Platform Fracture Stem is an exciting 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.”
Exactech said that it is conducting clinical evaluations of the shoulder fracture stem this quarter, with full market launch targeted for the second half of 2010. According to industry reports, the number of shoulder replacement procedures increased more than 10 percent to just over 70,000 procedures in 2009. Of these procedures, there has been significant growth in the use of reverse shoulder prostheses.
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