ASTM F2887-12 - 15.12.2012
 
1. Scope

1.1 This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement (“hemi”) prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.

1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.

1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device that will provide satisfactory clinical performance.

1.4 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

F732-17(2025)

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

F746-04(2021)

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

F748-25

Standard Practice for Selecting Biological Test Methods for Materials and Devices

F799-25

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

F983-24

Standard Practice for Permanent Marking of Orthopaedic Implant Components

F1044-25

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

F1108-21

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

F1147-24

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

F1160-25

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

F1223-20

Standard Test Method for Determination of Total Knee Replacement Constraint

F1377-21

Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)

F1472-23

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

F1537-20

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

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 for Test

F75-23

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

F648-21

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

F565-26

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

F451-21

Standard Specification for Acrylic Bone Cement

F136-26

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

F90-24

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

F86-21(2026)

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

F2759-25

Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Joint Implant Devices

F1814-22

Standard Guide for Evaluating Modular Hip and Knee Joint Components

F1580-18

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

ISO 10993

Biological Evaluation of Medical Devices--Part I: Evaluation and Testing Within a Risk Management Process

ISO 6018

Orthopaedic Implants--General Requirements for Marking, Packaging, and Labeling

ISO 5834–2

Implants for Surgery--Ultra High Molecular Weight Polyethylene--Part 2: Moulded Forms

ISO 5832–12

Implants for Surgery--Metallic Materials--Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy

ISO 5832–3

Implants for Surgery--Metallic Materials--Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy

ISO 5832–4

Implants for Surgery--Metallic Materials--Part 4: Cobalt-Chromium-Molybdenum Casting Alloy