Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

038

Date of Entry 01/27/2015 

FR Recognition Number

8-385

Standard

ASTM F648-14
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Scope/Abstract

1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.

1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.

1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants.

1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3)2 and by laboratory studies (4, 5, 6).

1.5 The values stated in SI units are to be regarded as standard.

1.6 The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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 and health 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.

Transition Period

FDA recognition of ASTM F648-14 [Rec# 8-385] will be superseded by recognition of ASTM F648-21 [Rec# 8-569]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-385] until December 18th, 2022. After this transition period, declarations of conformity to [Rec# 8-385] will not be accepted.

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

Regulation Number	Device Name	Device Class	Product Code
§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
§888.3540	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class 2	KRR
§888.3500	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	Class 2	KYK
§888.3150	Prosthesis, Elbow, Constrained, Cemented	Class 2	JDC
§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	Prosthesis, Subtalar, Plug, Polymer	Class 2	MJW
§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
§888.3040	Transtibial Anterior Cruciate Ligament Kit	Class 2	PPQ
§888.3040	Sacroiliac Screw Placement Guide	Class 2	QSR
§888.3110	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class 2	HSN
§888.3110	Ankle Arthroplasty Implantation System	Class 2	OYK
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC
§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
§888.3510	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class 2	KRO
§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
§888.3560	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
§888.3660	Shoulder Arthroplasty Implantation System	Class 2	QHE
§888.3660	Total Shoulder Arthroplasty System	Class 2	QHQ
§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
§888.3350	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
§888.3520	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class 2	HSX
§888.3670	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	MBF

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

 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.