Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 8-226: ASTM F603-12, Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application. (Materials)
Date of Standard: 2012. |
| 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: |
| Femoral Head and Acetabular Liner Components of Total Hip Replacements (THR), Abutments for Endosseus Dental Implants |
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| Processes Affected: |
| 510(k), IDE, HDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
Complete Standard
This specification covers the material requirements for high-purity, dense aluminum oxide (i.e., alumina - Al2O3) for load bearing surgical implant applications. It does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants, and the like). It is intended as a qualification of the material as delivered to the parts manufacturer. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3 |
LPF |
| Unclassified |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3 |
MRA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3630 |
Abutment, Implant, Dental, Endosseous |
Class 2 |
NHA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
Class 2 |
OQI |
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
Class 2 |
MAY |
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Class 2 |
LZO |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer |
Class 3 |
KXB |
| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented |
Class 3 |
OCG |
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| Relevant Guidance: |
Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, January 10, 1995.
Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments ? Guidance for Industry and FDA Staff, May 12, 2004. |
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| FDA Technical Contacts: |
| Daniel Clupper |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2572 |
| Silver Spring MD 20993 |
| 301/796-6473 |
| Email: daniel.clupper@fda.hhs.gov |
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| Peter Allen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Building 66, Room 1512 |
| Silver Spring MD 20993 |
| 301/796-6402 |
| Email: peter.allen@fda.hhs.gov |
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