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.
1.1 This specification is intended to cover all the widely used generic types of knee replacement prostheses used to provide functioning articulation. This includes total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses of both fixed and mobile bearing varieties, and for primary or revision surgeries. 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 F1672.
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.
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. However, compliance with this specification does not itself define a device that will provide adequate clinical performance.
1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; and patellofemoral prostheses. Also excluded are devices designed for custom applications.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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)
ISO14243–3 Implants for Surgery--Wear of Total Knee-Joint Prostheses--Part 3: Loading and Displacement Parameters for Wear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
USFDA21CFR888.6 Degree of Constraint Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://www.fda.gov.
ANSI/ASMEB46.1 Surface Texture (Surface Roughness, Waviness, and Lay)
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 Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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