Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021 

FR Recognition Number

8-572

Standard

ASTM  F2565-21
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

Scope/Abstract

1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648.

1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.

1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.

1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.

1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.

1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to 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.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§888.3040	Pin, Fixation, Smooth	Class 2	HTY
§888.3040	Screw, Fixation, Bone	Class 2	HWC
§888.3040	Pin, Fixation, Threaded	Class 2	JDW
§888.3040	Component, Traction, Invasive	Class 2	JEC
§888.3040	Fastener, Fixation, Nondegradable, Soft Tissue	Class 2	MBI
§888.3040	Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component	Class 2	MRY
§888.3040	Screw, Fixation, Bone, Non-Spinal, Metallic	Class 2	NDJ
§888.3040	System, External Fixator (With Metallic Invasive Components)	Class 2	NDK
§888.3040	Pin, Fixation, Smooth, Metallic	Class 2	NDL
§888.3040	Pin, Fixation, Threaded, Metallic	Class 2	NDM
§888.3040	Accessory, System, External Fixator, Containing Antimicrobial Agent	Class 2	NJA
§888.3040	Laparoscopic Bone Anchor Urethropexy Instrument Kit	Class 2	NWN
§888.3040	Sacroiliac Joint Fixation	Class 2	OUR
§888.3040	Pin, Fixation, Resorbable, Hard Tissue	Class 2	OVZ
§888.3110	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class 2	HSN
§888.3110	Ankle Arthroplasty Implantation System	Class 2	OYK
§888.3150	Prosthesis, Elbow, Constrained, Cemented	Class 2	JDC
§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
§888.3340	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
§888.3350	Acetabular Cup Orientation System	Class 2	PLW
§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, Uncemented, Metal/Polymer, Porous	Class 2	MBL
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY
§888.3490	Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented	Class 2	KMB
§888.3490	Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented	Class 2	KTX
§888.3500	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	Class 2	KYK
§888.3510	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class 2	KRO
§888.3520	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class 2	HSX
§888.3530	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class 2	HRY
§888.3530	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing	Class 2	LGE
§888.3535	Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	Class 2	NJD
§888.3540	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class 2	KRR
§888.3560	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class 2	JWH
§888.3560	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Class 2	MBV
§888.3560	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class 2	NPJ
§888.3560	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class 2	OIY
§888.3560	Knee Arthroplasty Implantation System	Class 2	OOG
§888.3650	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class 2	KWT
§888.3660	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class 2	KWS
§888.3660	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Class 2	PAO
§888.3660	Shoulder Prosthesis, Reverse Configuration	Class 2	PHX
§888.3660	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Class 2	PKC
§888.3670	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	MBF
§888.3800	Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained	Class 2	JWI
§888.3800	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Class 2	JWJ
§888.3800	Prosthesis, Wrist, Semi-Constrained	Class 2	KWM
§888.3810	Prosthesis, Wrist, Hemi-, Ulnar	Class 2	KXE
§888.4210	Mixer, Cement, For Clinical Use	Class 1	JDZ

Relevant FDA Guidance and/or Supportive Publications*

Guidance for Industry and FDA Staff: Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, 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

 Jinrong (Jinny) Liu

  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/

  240-402-3160

  jinrong.liu@fda.hhs.gov

Standards Development Organization

ASTM ASTM International http://www.astm.org/

FDA Specialty Task Group (STG)

Materials

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