OMNIlife science, Inc. Announces PS Knee FDA ClearanceBy Omnilife Science Inc., PRNE
Monday, July 4, 2011
EAST TAUNTON, Massachusetts, July 5, 2011 -
OMNIlife science, Inc. (a subsidiary of
Orthopaedic Synergy, Inc.) today announced clearance of its Apex PS
Knee by the United States Food and Drug Administration. The
Apex Posterior Stabilized (PS) Knee is the latest addition to the
Apex Knee product family. The new design was introduced into
the European market in the second half of 2010 and has been
positively received by surgeons and patients. It is now being
introduced into the U.S. market with a full launch expected by the
end of 2011. The Apex PS Knee maintains the key design
elements of the existing Apex Cruciate Retaining (CR) Knee but
offers the post and cam system preferred by surgeons who utilize a
posterior stabilized knee replacement. The innovative design
allows the Apex PS Knee to have up to an additional 30 degrees of
uninterrupted patella track compared to competitive posterior
stabilized knee designs that require a larger bone resection.
The extra patella track potentially reduces the chance of
experiencing a problem that has been associated with knee
replacements known as patella “clunk”. A single step reaming
process allows a seamless intraoperative transition from a CR Knee
to a PS Knee based on surgeon preference. By taking advantage
of the intercondylar fossa for the location of the Apex PS Knees’
“box” cut, there is as much as a 90% reduction in the bone removed
compared to some competitive PS knee designs.
“We believe that the design of the Apex
PS Knee will set a new standard in the Orthopaedic industry that
will benefit both patients and surgeons,” said George Cipolletti,
Chief Executive Officer of OMNIlife science, Inc. and Orthopaedic
“I really enjoy using the instruments
for the Apex PS knee; it’s certainly the easiest and most
repeatable box cut that I have ever made,” said Anthony F. Infante,
Jr., D.O. “In the past, I’ve typically used an ultra congruent
insert for posterior stabilization because of the amount of bone
that was removed in a typical PS Knee. With the OMNI system, the
amount of additional bone that is removed is so insignificant I
have no problem using this PS Knee in all of my patients.”
OMNIlife science, Inc. was founded in
1999 as an organization committed to the design, manufacture and
distribution of high quality, innovative orthopaedic devices.
Corporate headquarters are located in East Taunton,
Massachusetts. OMNI’s products are prescribed by orthopaedic
surgeons for their patients who require total joint replacement.
By continuing to challenge the design and functionality of
our products based on persistent advances in reconstructive
surgical techniques, anatomic and biomechanical data, as well as
input from surgeons, the Company is emerging as a leader in modular
hip stem technology and total knee replacement systems.
Additional information can be found at
Orthopaedic Synergy, Inc. functions as
a holding company for OMNIlife science, Inc., Enztec Limited and
PRAXIM, SA. Together these companies represent a global
reconstructive orthopaedic concern that is committed to the design,
manufacture and distribution of high quality orthopaedic devices.
Company objectives include continued growth through strategic
acquisition of organizations with complementary technology.
The goal is to acquire firms that enhance the development of
line extensions to our company’s current product offerings as well
as innovative new products that provide improved clinical options
for our customers. Additional information can be found at
Lisa A. Cabral, MBA, Corporate Communications Manager, +1-774-226-1874, lcabral at omnils.com
Tags: East Taunton, July 5, Massachusetts, Omnilife Science Inc.