Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-220: ASTM F2068-09, Standard Specification for Femoral Prostheses - Metallic Implants. (Orthopaedics)
Date of Standard: 2009. |
| 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 Components of Total Hip Replacement (THR) and Hemi-Hip Replacements |
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| Processes Affected: |
| 510(K), IDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
Complete standard.
Regarding clauses 6.1.1 and 6.1.2 in ASTM F2068-09, for stems 250mm in length as defined in ISO 7206-4: 2010, one should reference ISO 7206-4: 2010 and its corresponding FDA Supplementary Information Sheet.
Standard provides femoral component fatigue test methods. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data must 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 |
| 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 |
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Class 2 |
LZO |
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
Class 2 |
MEH |
| §888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
LWJ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3300 |
Prosthesis, Hip, Constrained, Metal |
Class 3 |
KXD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
Class 2 |
KWZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
Class 3 |
JDL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
Class 3 |
KWA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal |
Class 2 |
KMC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
Class 2 |
OQH |
| §888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Class 2 |
JDI |
| |
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 |
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
Class 2 |
MEH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Class 2 |
OQG |
| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Class 2 |
LPH |
| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
Class 2 |
MBL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal |
Class 2 |
KWL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3360 |
Prosthesis, Hip, Femoral Component, Cemented, Metal |
Class 2 |
JDG |
| §888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal |
Class 2 |
KWL |
| §888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
LWJ |
| §888.3360 |
Prosthesis, Upper Femoral |
Class 2 |
JDD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Class 2 |
KWY |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, September 17, 2007 |
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| FDA Technical Contact: |
| John Goode |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1510 |
| Silver Spring MD 20993 |
| 301/796-6407 |
| Email: john.goode@fda.hhs.gov |
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