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ASTM F1672-14(2019)

Current Revision

Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)

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1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between 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.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


This specification covers the basic material descriptions, device geometry (axisymmetric and nonsymmetric), and in-vivo performance characteristics of patellar resurfacing prosthetic devices used to provide a functioning articulation between the bones of the patella and the femur. This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001. All devices conforming to this specification shall be fabricated from materials with adequate mechanical strength and durability, corrosion resistance, and biocompatibility. In the evaluation of their safety and efficacy, patella prosthesis shall adhere to the minimum acceptance criteria specified for the following failure modes: dislocation or laterial subluxation; component disassociation; fixation failure; device fracture; and articular surface wear.


SDO ASTM: ASTM International
Document Number F1672
Publication Date Aug. 15, 2019
Language en - English
Page Count 5
Revision Level 14(2019)
Supercedes
Committee F04.22
Publish Date Document Id Type View
Aug. 15, 2019 F1672-14R19 Revision
April 1, 2014 F1672-14 Revision
Jan. 1, 2000 F1672-95E01 Revision
March 1, 2011 F1672-95R11 Reaffirmation
Oct. 1, 2005 F1672-95R05 Reaffirmation
Jan. 1, 2000 F1672-95R00 Reaffirmation