1. Scope

1.1 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. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F 1672.

1.2 Included within the scope of this specification are 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. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.

1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined.

1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

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/F2083-06A

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