FDA Clears Chemically Crosslinked UHMWPE for Total Knees

Total Joint Orthopedics received FDA 510(k) clearance to market its Klassic Knee with AlchemXE chemically crosslinked ultra-high molecular weight polyethylene (UHMWPE) technology developed by Alchimist.

The Klassic Knee is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D and the Klassic Tibial Baseplate with Ti-Coat, which are indicated for cementless use.

AlchemXE blends dicumyl peroxide and vitamin E with UHMWPE during consolidation, then uses proprietary technology to crosslink the material, resulting in high wear resistance and long-term oxidative stability without the need for radiation crosslinking. A proprietary heat treatment improves the mechanical properties and reduces the by-products of the peroxide chemistry.

Implants machined from AlchemXE are terminally gamma sterilized without any loss of oxidative stability. Alchimist partnered with Restoration Medical Polymers for the development and large-scale production of this novel UHMWPE technology.

Source: Alchimist

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