Abstract

This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110? of flexion to high flexion. Replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement are described. Primary and revision prostheses and also covers fixed and mobile bearing knee designs are discussed. Basic descriptions of material and prosthesis geometry are provided. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined. The prostheses are classified into three kinds according to degree of constraint. The first kind is considered constrained which prevents dislocation of the prosthesis in more than one anatomic plane and consists of either a single, flexible, across-the-joint component or more than one component linked together or affined. The second one is a semiconstrained joint prosthesis which limits translation or rotation, or both, of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no across-the-joint linkages. The third kind is a nonconstrained joint prosthesis which minimally restricts prosthesis movement in one or more planes. Its components have no across-the-joint linkages. The choice of materials is understood to be a necessary but not sufficient assurance of function of the device made from them. All devices shall be fabricated from materials with adequate mechanical strength and durability, corrosion resistance, and biocompatibility.

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

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

F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

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)

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

F1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

F1223 Test Method for Determination of Total Knee Replacement Constraint

F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

F1580 Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

F1672 Specification for Resurfacing Patellar Prosthesis

F1800 Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

F1814 Guide for Evaluating Modular Hip and Knee Joint Components

F2384 Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

ISO Standards

FDA Document

ANSI/ASME Standard

Keywords

arthroplasty; contact area; contact pressure; fatigue; knee; knee constraint; knee prosthesis; knee wear; particles; surface roughness; total knee replacement; TKR; unicondylar knee replacement (UKR); UHMWPE;

ICS Code

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

DOI: 10.1520/F2083-12

ASTM International is a member of CrossRef.

ASTM F2083