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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 057 Date of Entry 12/20/2021 
FR Recognition Number 8-569
Standard
ASTM  F648-21
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 and by laboratory studies.
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 Smooth or threaded metallic bone fixation fastener.
§888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
§888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
§888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
§888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
§888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
§888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
§888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
§888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
§888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
§888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
§888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
§888.3535 Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
§888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
§888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
§888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
§888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
§888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
§888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
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.
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