Abstract
This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation. Acetabular prostheses shall be classified as: Type I and Type II. The following test methods shall be performed: mechanical strength; corrosion resistance; biocompatibility; structural requirements; metal and ceramic coating or surface texture integrity; component disassociation; fixation failure; device fracture; and articular surface wear.
Scope
1.1 This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.
1.2 This specification 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.
1.3 Acetabular prostheses included within the scope of this specification are intended for fixation by press-fit between the prosthesis and host bone, the use of bone cement, the use of bone screws or similar means of mechanical fixation, or through biological fixation of host bone and/or soft connective tissue into a porous surface.
1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this specification.
1.5 This specification does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.
