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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 11-321
Standard
ASTM  F2887-17
Standard Specification for Total Elbow Prostheses
Scope/Abstract
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 will provide satisfactory clinical performance.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F2887-17 [Rec# 11-321] will be superseded by recognition of ASTM F2887-23 [Rec# 11-404]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-321] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 11-321] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3150 Prosthesis, Elbow, Constrained, Cemented Class 2 JDC
§888.3160 Prosthesis, Elbow, Semi-Constrained, Cemented Class 2 JDB
§888.3170 Prosthesis, Elbow, Hemi-, Radial, Polymer Class 2 KWI
§888.3180 Prosthesis, Elbow, Hemi-, Humeral, Metal Class 3 KWJ
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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