Exactech Receives FDA 510(k) Clearance for Vantage™ Total Ankle

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech Inc. (Nasdaq:EXAC), a developer and producer of bone and joint
restoration products for extremities, knee, hip, spine and biologic
materials, announced today it has received clearance from the U.S. Food
and Drug Administration to market the Vantage™ Total Ankle to treat
patients who suffer from arthritis in the ankle. The Vantage Total Ankle
is the latest product in the company’s extremities line, and its first
in the foot and ankle market.

“With the introduction of the Vantage Ankle, Exactech continues its
precedent of innovation in the extremities market, which began with our
industry-leading Equinoxe^® platform shoulder system,” said
Darin Johnson, Exactech vice president of marketing for extremities.
“The ankle market is in need of advances in total ankle technologies. We
have had the pleasure of working with a world-class design team that
includes surgeons who have dedicated their careers to treatment of the
ankle. Together, we have developed an implant that we believe will be an
improvement for patients who need a total ankle.”
“I am impressed with Exactech’s ability to convert concepts from their
other successful total joint replacement systems,” said Mark Easley, MD,
design team member and president of the American Orthopaedic Foot and
Ankle Society. “The company’s engineers have successfully turned our
ideas into an exciting new treatment option for end-stage ankle
arthritis. On behalf of the design team and engineers, I look forward to
sharing the Vantage ankle with other surgeons so their patients may
benefit from this meaningful new technology.”
Designed to conserve bone, the Vantage Total Ankle is an easy-to-use
solution that allows for both stability and mobility in total ankle
arthroplasty. The curved surface talar component is engineered to fit
the anatomy of the diseased talus and restore the joint line, and both
the curved talus and anatomic tibia designs are intended to improve
implant stability and return anatomic kinematics. The system
incorporates the signature press-fit bone cage design used in the
Equinoxe shoulder system, developed to allow for initial and long-term
fixation.
Exactech plans to initiate targeted clinical evaluation of the
fixed-bearing Vantage Total Ankle this summer, with full-scale release
scheduled for the first quarter of 2017.
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 https://www.exac.com.
Copies of Exactech’s press releases, SEC filings, current price quotes
and other valuable information for investors may be found at https://www.exac.com
and https://www.hawkassociates.com.
An investment profile on Exactech may be found at https://www.hawkassociates.com/profile/exac.cfm.
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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.