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ASTM F2091-01(2006)

Historical Reaffirmation

Standard Specification for Acetabular Prostheses (Withdrawn 2023)

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

1.2 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.

1.3 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.

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

1.5 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.


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.


SDO ASTM: ASTM International
Document Number F2091
Publication Date March 1, 2006
Language en - English
Page Count 5
Revision Level 01(2006)
Supercedes
Committee F04.22
Publish Date Document Id Type View
March 15, 2015 F2091-15 Revision
June 10, 2001 F2091-01 Revision
Jan. 15, 2012 F2091-01R12 Reaffirmation
March 1, 2006 F2091-01R06 Reaffirmation