Exactech Receives FDA 510(K) Clearance for Its Optetrak Logic® Constrained Condylar Prosthesis
June 25 2015 - 11:49AM
Business Wire
Clearance Welcome News for Knee Surgeons
with Complex Revision Knee Arthroplasty Cases
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.
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 and
http://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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150625005983/en/
Exactech, Inc.Jody Phillips, 352-377-1140Executive Vice
President of Finance &Chief Financial OfficerorHawk
AssociatesJulie Marshall or Frank Hawkins,
305-451-1888exac@hawkassociates.com
Exactech, Inc. (delisted) (NASDAQ:EXAC)
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