Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-242: ASTM F1839-08e2, Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. (Orthopaedics)
Date of Standard: 2008. |
| 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: |
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| Processes Affected: |
| 510(k), IDE, HDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| Vertical, National, Test Methods |
| Extent of Recognition: |
Complete standard
This specification lists the requirements for various physical and mechanical properties of various grades of polyurethane "bone substitute" blocks. When used to assess the performance of fixation devices in bone, care should be taken to select the worst-case grade for the intended use (e.g. insertion or pullout) and anatomic location. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3030 |
Fastener, Fixation, Biodegradable, Soft Tissue |
Class 2 |
MAI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3040 |
Fastener, Fixation, Nondegradable, Soft Tissue |
Class 2 |
MBI |
| §888.3040 |
Screw, Fixation, Bone |
Class 2 |
HWC |
| §888.3040 |
Screw, Fixation, Bone, Non-Spinal, Metallic |
Class 2 |
NDJ |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Michael Kasser |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1576 |
| Silver Spring MD 20993 |
| 301/796-6946 |
| Email: michael.kasser@fda.hhs.gov |
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