Stryker’s LFIT+X3 Bearing System Fits for FDA
Stryker Corporation announced today its orthopaedics division has obtained FDA 510(k) clearance for its premarket notification of a new bearing system. The hip implant technology combines LFIT anatomic femoral heads with X3 polyethylene liners. LFIT stands for Low Friction Ion Treatment, a materials technology meant to reduce coefficient of friction and improve wettability of the metal used to build artificial femoral heads. X3, the company’s new iteration of its Crossfire polyethylene, is a highly crosslinked polyethylene, i.e. a polymerized ethylene resin manufactured in a certain way, or in layman’s terms: high-grade plastics with specific properties. Its purpose is to offer reduced wear and produce less debris in the liners (the surface within which the head will fit).
The new product aims to reduce the number of costly post-operation disclocations in total hip replacements. Stryker plans to launch it globally in September. The FDA’s 510(k) database is updated once a month at about the 5th of each month for the prior month so it does not feature this product yet at the time we are writing this.
See also:
- Is Hip Resurfacing Ready for the US Market?
- Zimmer, Striker Give Info on DOJ Investigation Scope
- Orthopedic Manufacturing Under Pressure
August 25, 2006 Related topics: Product Approval & Certification, Orthopedic