ASTM F2083-21
Standard Specification for Knee Replacement Prosthesis

Standard No.

ASTM F2083-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2083-21

Scope

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 va

ASTM F2083-21 Referenced Document

• ANSI/ASME B46.1 Surface Texture, Surface Roughness, Waviness and Lay*， 2024-04-21 Update
• ASTM E739 Standard Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (949;-N) Fatigue Data
• ASTM F1108 Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406)
• ASTM F1223 Standard Test Method for Determination of Total Knee Replacement Constraint
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F1377 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM F1580 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
• ASTM F1672 Standard Specification for Resurfacing Patellar Prosthesis
• ASTM F1800 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• ASTM F1814 Standard Guide for Evaluating Modular Hip and Knee Joint Components
• ASTM F1877 Standard Practice for Characterization of Particles
• ASTM F2003 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air*， 2022-11-15 Update
• ASTM F2384 Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)*， 2024-04-21 Update
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment*， 2023-04-01 Update
• ASTM F2722 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops*， 2024-04-21 Update
• ASTM F2723 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation*， 2024-04-21 Update
• ASTM F2724 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation*， 2021-03-01 Update
• ASTM F2777 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion*， 2023-09-01 Update
• ASTM F2943 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
• ASTM F3140 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements*， 2023-09-12 Update
• ASTM F3141 Standard Guide for Total Knee Replacement Loading Profiles*， 2023-06-01 Update
• ASTM F3161 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions*， 2024-04-21 Update
• ASTM F451 Standard Specification for Acrylic Bone Cement
• ASTM F561 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
• ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)*， 2022-01-01 Update
• ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants*， 2021-04-01 Update
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F732 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• ASTM F746 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F799 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants*， 2021-06-01 Update
• ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14243-1 Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
• ISO 14243-2 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
• ISO 14243-3 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
• ISO 6474-1 Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina

ASTM F2083-21 history

• 2021 ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis
• 2012 ASTM F2083-12 Standard Specification for Knee Replacement Prosthesis
• 2011 ASTM F2083-11 Standard Specification for Total Knee Prosthesis
• 2010 ASTM F2083-10 Standard Specification for Total Knee Prosthesis
• 2008 ASTM F2083-08e1 Standard Specification for Total Knee Prosthesis
• 2008 ASTM F2083-08 Standard Specification for Total Knee Prosthesis
• 2007 ASTM F2083-07 Standard Specification for Total Knee Prosthesis
• 2006 ASTM F2083-06b Standard Specification for Total Knee Prosthesis
• 2006 ASTM F2083-06a Standard Specification for Total Knee Prosthesis
• 2006 ASTM F2083-06 Standard Specification for Total Knee Prosthesis
• 2004 ASTM F2083-04 Standard Specification for Total Knee Prosthesis
• 2003 ASTM F2083-03 Standard Specification for Total Knee Prosthesis
• 2001 ASTM F2083-01a Standard Specification for Total Knee Prosthesis
• 2001 ASTM F2083-01 Standard Specification for Total Knee Prosthesis