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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 8-475
Standard
ASTM F2026-17
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Scope/Abstract
1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.

1.2 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.

1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices.

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FDA recognition of ASTM F2026-16 [Rec# 8-436] will be superseded by recognition of ASTM F2026-17 [Rec# 8-475]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-436] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 8-436] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 KTT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class 2 LXT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class 2 KTW
§888.3030 Appliance, Nail/Blade/Plate Combination, Single Component Class 2 KWK
§888.3030 Condylar Plate Fixation Implant Class 2 JDP
§888.3030 Device, Fixation, Proximal Femoral, Implant Class 2 JDO
§888.3030 Plate, Fixation, Bone Class 2 HRS
Relevant FDA Guidance and/or Supportive Publications
Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, Issued May 1995

Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems, Issued January 2000

Guidance for Industry and FDA Staff: Spinal System 510(k)s, Issued May 2004

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, Issued June 2007
FDA Technical Contacts
 Jinrong (Jinny) Liu
  FDA/OMPT/CDRH/ODE/DCD/ICDB/
  240-402-3160
  jinrong.liu@fda.hhs.gov
 John Goode
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
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