1.1This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur.
1.2This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined.
1.3This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001.