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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 065 Date of Entry 12/22/2025 
FR Recognition Number 11-437
Standard
ASTM  F2033-25
Standard Specification for Hip Joint Replacement Bearing Surfaces
Scope/Abstract
1.1 This specification covers the requirements for the mating bearing surfaces of total hip joint replacements and separate requirements for dual mobility hip joint replacements, intended for total hip arthroplasty; and partial hip joint replacements and separate requirements for bipolar femoral hip joint replacements, intended for hemiarthroplasty. All joint replacement implant types are defined in ISO 21535. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration.

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

1.3 This specification covers the requirements for the visual inspection, surface finish, and dimensional tolerances for the spherical concave mating surface of polyethylene acetabular components; and the requirements for the visual inspection, sphericity, surface finish, and diametral clearance for the spherical concave mating surface of metal and ceramic acetabular components of total hip joint replacements.

1.4 This specification covers the requirements for the visual inspection, sphericity, surface finish, and dimensional tolerances for the spherical metal or ceramic femoral heads of partial hip joint replacements.

1.5 This specification covers the requirements for the visual inspection, sphericity, surface finish, and dimensional tolerances for the spherical articulating metal or ceramic femoral heads of bipolar femoral hip joint replacements; the requirements for the visual inspection, surface finish, and dimensional tolerances for the inner polyethylene bearing surface of bipolar heads; the requirements for the visual inspection, sphericity, surface finish, and diametral clearance of the inner metal or ceramic bearing surface of bipolar heads; and the requirements for the visual inspection, sphericity, surface finish, and dimensional tolerances of outer metal or ceramic bearing surfaces of bipolar heads of bipolar femoral hip joint replacements.

1.6 This specification covers the requirements for the visual inspection, sphericity, surface finish, and dimensional tolerances for the spherical articulating metal or ceramic femoral heads of dual mobility hip joint replacements; the requirements for the visual inspection, surface finish, and dimensional tolerances for the inner polyethylene bearing surface of dual mobility heads; the requirements for the visual inspection, sphericity, and surface finish of outer polyethylene bearing surface of dual mobility heads; and the requirements for the visual inspection, sphericity, surface finish, and diametral clearance requirements for the spherical concave mating surface of metal and ceramic acetabular components of dual mobility hip joint replacements. ...
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 F2033-20 [Rec# 11-376] will be superseded by recognition of ASTM F2033-25 [Rec# 11-437]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-376] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 11-376] will not be accepted.
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
 Lindsay Jeffries
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA
  301-796-3740
  Lindsay.Jeffries@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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