Thursday, June 25, 2015

News: Exactech Receives FDA 510(K) Clearance for Its Optetrak Logic® Constrained Condylar Prosthesis | Clearance Welcome News for Knee Surgeons with Complex Revision Knee Arthroplasty Cases

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GAINESVILLE, Fla.--()--Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today it has received clearance from the U.S. Food and Drug Administration to market the Optetrak Logic® Constrained Condylar (CC) Prosthesis for revision knee arthroplasty cases.
“The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes. Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss.”
Exactech CEO David Petty said, “The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes. Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss.”
A surgeon-focused, patient-driven innovation, Optetrak Logic CC offers a modern solution for reproducibility in the most complex and challenging knee arthroplasty cases. The new addition to Exactech’s clinically recognized knee system introduces an advanced implant system and precision tools to consistently achieve optimized implant placement and bone coverage.
The Optetrak Logic CC Prosthesis is indicated for use in patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; this device is also indicated for when previous devices have failed.
Surgeons around the world have documented excellent Optetrak® results.1 Offering advanced approaches to knee replacement, the Exactech Knee system combines a clinically-recognized system of proven implant system with personalized surgical workflows for reproducible outcomes, case after case.
The Optetrak Logic CC system will have limited availability in 2015, ramping up to a full market launch in 2016.
For more information about the Exactech Knee system, visit www.exac.com.
1 Data on file at Exactech, Inc.
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, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at http://www.exac.com. 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 andhttp://www.hawkassociates.com.
An investment profile on Exactech may be found at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.
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.

Contacts

Exactech, Inc.
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888

Published at Business Wire

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