Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

061

Date of Entry 09/11/2023 

FR Recognition Number

11-401

Standard

ISO  21535 Third edition 2023-07
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

Scope/Abstract

This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials.

This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2.

The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant's sufficient and safe clinical use.

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FDA recognition of ASTM F2068-15 [Rec# 11-299] and ASTM F2091-15 [Rec# 11-301] will be superseded by recognition of ISO 21535 Third edition 2023-07 [Rec# 11-401]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-299] and [Rec# 11-301] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 11-299] and [Rec# 11-301] 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
§888.3360	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Class 2	LZY
§888.3370	Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal	Class 3	KWB
§888.3380	Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal	Class 3	JDH
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY
§888.3400	Prosthesis, Hip, Femoral, Resurfacing	Class 2	KXA
§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*

1. Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, issued April 1994.

2. Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, issued January 1995.

3. Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components, issued May 1995.

4. 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, issued February 1997.

5. Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements, issued February 2000.

6. Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA, issued April 2002.

7. Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, issued September 2007.

8. Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff, issued September 2016.

9. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff, issued April 2019.

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

ISO International Organization for Standardization https://www.iso.org/

FDA Specialty Task Group (STG)

Orthopedic

*These are provided as examples and others may be applicable.