GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today 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.
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 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.
About Exactech
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States and Australia, in addition to more than 30 countries in Europe, Asia and Latin America. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com and http://www.hawkassociates.com.
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This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.
