Healthcare Industry News:  joint replacement 

Devices Orthopaedic FDA

 News Release - August 25, 2006

Stryker(R) Receives FDA Clearance for LFIT(TM) Anatomic Femoral Heads with X3(R) Liners

Anatomic Heads Designed to Maximize Hip Stability, Reduce Risk of Dislocation and Lower Associated Healthcare Costs

KALAMAZOO, Mich., Aug. 25 (HSMN NewsFeed) -- Stryker Corporation (NYSE: SYK ) announced today that its Orthopaedics division has received FDA 510(k) clearance for its advanced bearing system, LFIT Anatomic Femoral Heads with X3 Polyethylene liners. A significant advancement in hip bearing technology, the new implant system combines Stryker's Low Friction Ion Treatment (LFIT) technology with Stryker's X3 advanced bearing technology and is anatomically sized for more natural hip performance. The result is total hip replacement designed to help minimize dislocation and its associated healthcare costs, while providing an attractive alternative to metal on metal bearings.

LFIT Anatomic Femoral Heads with X3 liners provides a combination of two advanced technologies pioneered by Stryker. "Up until now, metal on metal options in larger sizes only met the needs of a subset of the total hip population. We are excited that Anatomic Heads with X3 liners will help post- operative orthopaedic patients achieve their lifestyle recovery objectives," said Mike Mogul, President, Stryker Orthopaedics.

Hip dislocation is a major complication in total hip replacement for patients, surgeons, hospitals and payers alike and is estimated to cost the U.S. Healthcare System $74 million per year. Three to four percent of Medicare patients receiving total hip replacements experience hip dislocation.(1)

"We remain committed to offering our customers technological advancements that improve patient outcomes. In today's healthcare environment these advancements must responsibly address both performance and economic issues," said Mike Mogul.

Stryker plans to initiate the global launch of LFIT Anatomic Heads with X3 liners starting in September.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly-based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. Stryker also provides outpatient physical therapy services in the United States. The Company's website address is http://www.stryker.com

(1) Sanchez-Sotelo J., et al., "Hospital cost of Dislocation After Primary total Hip Arthroplasty," Journal of Bone and Joint Surgery, May 30, 2006, pg. 290


Source: Stryker

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