Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 8-203: ASTM F 2026-10, Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. (Materials)
Date of Standard: 2010. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
| The material specification can affect a number of orthopedic implants. Examples: fusion cages, pedicle screws, and osteosynthesis plates and screws. |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, Design Controls |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete standard.
Test methods provided covers the material specification for PEEK polymer in virigin forms as supplied by a vendor (pellet, powder, and so forth). It provides requirements and associated test methods for these theromplastics when they are to be used in the manufacturing of surgical implants. Additional information should be provided to document that the design of the product will provide adequate mechanical properties for the particular application. Where the standard allows the user to select test parameters, additional information should be provided to describe and justify the test parameters selected. In applications subjected to wear or articulation, additional data should be provided to document resistance to wear and abrasion. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3040 |
Screw, Fixation, Bone |
Class 2 |
HWC |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3060 |
Spinal Vertebral Body Replacement Device |
Class 2 |
MQP |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation |
Class 2 |
MNI |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Class 3 |
NKB |
| §888.3070 |
Orthosis, Spondylolisthesis Spinal Fixation |
Class 2 |
MNH |
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| Relevant Guidance: |
Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, May 1, 1995
Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000
Guidance for Industry and FDA Staff: Spinal System 510(k)s, May 3, 2004
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007 |
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| FDA Technical Contact: |
| Hany Demian |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1528 |
| Silver Spring MD 20993 |
| 301/796-6420 |
| Email: hany.demian@fda.hhs.gov |
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