| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
|
|
FR Recognition Number
|
8-643
|
| Standard | |
ASTM F2820-24
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
|
Scope/Abstract1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) and fabricated forms. 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 PEKK polymers only. Indicated properties are for fabricated forms. Fabricated forms and materials containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEKK, or reclaimed materials are not covered by this specification. |
|
| Extent of Recognition
|
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| FDA recognition of ASTM F2820-12(2021)e1 [Rec# 8-574] will be superseded by recognition of ASTM F2820-24 [Rec# 8-643]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-574] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-574] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3030 |
Plate, Fixation, Bone
|
Class 2
|
HRS
|
| §888.3030 |
Device, Fixation, Proximal Femoral, Implant
|
Class 2
|
JDO
|
| §888.3030 |
Condylar Plate Fixation Implant
|
Class 2
|
JDP
|
| §888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
Class 2
|
KTT
|
| §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 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
|
Class 2
|
LXT
|
| §888.3040 |
Screw, Fixation, Bone
|
Class 2
|
HWC
|
| §888.3060 |
Spinal Vertebral Body Replacement Device
|
Class 2
|
MQP
|
| §888.3070 |
Orthosis, Spondylolisthesis Spinal Fixation
|
Class 2
|
MNH
|
| §888.3070 |
Orthosis, Spinal Pedicle Fixation
|
Class 2
|
MNI
|
| §888.3070 |
Thoracolumbosacral Pedicle Screw System
|
Class 2
|
NKB
|
|
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 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.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
|
|
