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Invibio’s PEEK-OPTIMA Polymer Used in Aesculap’s FDA 510(k) Cleared EnduRo Rotational Knee System

Invibio Biomaterial Solutions, provider of PEEK-based biomaterial solutions to medical device manufacturers around the world, announced that its PEEK-OPTIMA® Carbon Fibre Reinforced (CFR) polymer is utilized in Aesculap’s FDA 510(k) cleared and CE-Marked EnduRo knee revision system. Developed to combat the predominant causes of knee implant failure, luxation, wear and malpositioning associated with metal components, Aesculap’s EnduRo knee revision system relies on PEEK-OPTIMA CFR polymer to increase the implant service life and reduce the necessity of subsequent revision surgery. Through use of PEEK-OPTIMA CFR polymer, the service life of the EnduRo knee implant system rotational hinge mechanisms matches that of established primary condylar implants.

The EnduRo knee is used in the treatment of severe bone defects and insufficiency of the ligamented apparatus. It has been commercially available in Europe since January 2010 and received FDA 510k clearance in December 2010 - only 6 months after submission.

A contributing factor to its fast FDA clearance time is Invibio’s accomplished history of use in FDA-cleared long term implantable devices and the wealth of data Invibio provides to support companies through their submission process. According to Aesculap, the EnduRo knee has received strong European market reception, gaining a 14% market share in Germany during the first year of availability and with more than 2000 prostheses implanted to date. Whilst in the US, Aesculap received a strong launch into the market with the first implantation of the EnduRo knee in November 2011. (Source: Invibio Biomaterial Solutions)