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.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. 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 1Devices for custom applications are not covered by this specification.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F451 Specification for Acrylic Bone Cement

F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563)

F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application

F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications

F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F983 Practice for Permanent Marking of Orthopaedic Implant Components

F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

ISO Standard

Keywords

arthroplasty; patella; prosthesis; Joint prostheses--specifications; Patellar prosthesis; Prostheses--specifications; Resurfacing patellar prosthesis; Surgical implants--specifications;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1672-95R11

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ASTM F1672