ARLINGTON, Tenn.--(BUSINESS WIRE)--July 15, 2004--
Notification Completes Clearance for Products Currently In Wright's
ALLOMATRIX(R) Line of Allograft Bone Void Fillers
Wright Medical Group, Inc. (NASDAQ:WMGI), a global orthopaedic
medical device company specializing in the design, manufacture and
marketing of reconstructive joint devices and biologic materials,
today announced receipt of marketing clearance from the United States
Food and Drug Administration (FDA) for ALLOMATRIX(R) C, ALLOMATRIX(R)
Custom, and ALLOMATRIX(R) DR bone graft putties that contain
demineralized bone matrix (DBM) and specific volumes and
configurations of donor matched, cancellous bone chips. Following the
FDA-clearance of ALLOMATRIX(R) Injectable Putty in March of this year,
today's regulatory announcement completes the clearance process for
Wright's entire ALLOMATRIX(R) family of products.
The Company began the 510(k) premarket notification process in
March of 2002, following FDA's clarification to all allograft putty
providers that such products are considered medical devices and are
therefore regulated under the federal Food, Drug, and Cosmetic Act.
The Company has satisfied FDA's medical device requirements for
demonstrating substantial equivalence, including endpoints established
for each product's clinical performance and viral inactivation
potential. The ALLOMATRIX(R) family of products and OSTEOSET(R) 2 DBM
are the only commercially available, FDA-cleared products which
contain demineralized bone matrix (DBM).
Laurence Fairey, President and Chief Executive Officer, commented,
“Wright Medical has demonstrated a successful strategy of using these
specialized formulations to address individual clinical needs targeted
at individual orthopaedic sub-specialties. Wright's ability to
understand and address specific surgical requirements by developing
these focused products reinforces the Company's growing reputation for
its comprehensive understanding and responsiveness to the expanding
bio-orthopaedic market.”
About Wright
Wright Medical Group, Inc. is a global orthopaedic medical device
company specializing in the design, manufacture and marketing of
reconstructive joint devices and biologic materials. The Company has
been in business for more than 50 years and markets its products in
over 40 countries worldwide. For more information about Wright, visit
our website at www.wmt.com.
This press release may contain “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements made in this press release, other than statements of
historical fact, are forward-looking statements. Forward-looking
statements reflect management's current knowledge, assumptions,
beliefs, estimates, and expectations and express management's current
views of future performance, results, and trends. The Company wishes
to caution readers that actual results might differ materially from
those described in the forward-looking statements. Forward-looking
statements are subject to a number of risks and uncertainties,
including the factors discussed in the Company's filings with the
Securities and Exchange Commission (including the Company's annual
report on Form 10-K for the year ended December 31, 2003), which could
cause the Company's actual results to materially differ from those
described in the forward-looking statements. Although the Company
believes that the forward-looking statements are accurate, there can
be no assurance that any forward-looking statement will prove to be
accurate. A forward-looking statement should not be regarded as a
representation by the Company that the results described therein will
be achieved. The Company wishes to caution readers not to place undue
reliance on any forward-looking statement. The forward-looking
statements are made as of the date of this press release. The Company
assumes no obligation to update any forward-looking statement after
this date.
CONTACT: Wright Medical Group Inc., Arlington
John K. Bakewell, 901-867-4527
