scope:

Scope

This standard describes acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.

This standard is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined.

Acetabular prostheses included within the scope of this standard are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation.

Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this standard.

This standard does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.