scope:

1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the bones of the patella and the femur.

1.2 This 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.

1.3 This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001.

Note 1--Devices for custom applications are not covered by this specification.