Abstract
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.
Scope
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.
