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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 056 Date of Entry 06/07/2021 
FR Recognition Number 11-376
Standard
ASTM  F2033-20
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
Scope/Abstract
1.1 This specification covers the requirements for the mating bearing surfaces of total hip joint prostheses or resurfacing hip devices, intended for total hip arthroplasty; and hip endoprostheses, intended for hemiarthroplasty. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration.

1.2 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical articulating metallic or ceramic femoral heads of total hip joint prostheses.

1.3 This specification covers the sphericity, and surface finish requirements for the spherical concave mating surface of metallic and ceramic acetabular components, and the surface finish requirements and dimensional tolerances for the spherical concave mating surface of polymeric acetabular components.

1.4 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical metallic or ceramic femoral heads of hip endoprostheses.

1.5 This specification covers the surface finish requirements and dimensional tolerances for the inner polymeric bearing surface of bipolar hip components, and the sphericity and surface finish requirements of the inner metallic or ceramic bearing surface of bipolar hip components; and the sphericity, surface finish requirements, and dimensional tolerances of outer metallic or ceramic bearing surfaces of bipolar hip components of hip endoprostheses.

1.6 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces. Additionally, the tolerances imposed on the polymeric portion of the bearing surface are intentionally large due to temperature-induced changes and other manufacturing concerns. Some manufacturing methods or designs may intentionally reduce the diameter of the polymeric bearing to more closely mate with the diameter of the head.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class 2 PBI
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
§888.3350 Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 OQH
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§888.3360 Prosthesis, Upper Femoral Class 2 JDD
§888.3360 Prosthesis, Hip, Femoral Component, Cemented, Metal Class 2 JDG
§888.3360 Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 KWL
§888.3360 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 LWJ
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer Class 3 KXB
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class 3 OCG
N/A Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
N/A Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
N/A Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing Class 3 NXT
N/A Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation Class 3 OVO
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems, issued January 1995.

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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