Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-225: ISO 7206-4 Third edition 2010-06-15, Implants for surgery - Partial and total hip-joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components. (Orthopaedics)
Date of Standard: 2010. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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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 replacements (THR) and hemi-hip replacements |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| Vertical, International, Test Methods |
| Extent of Recognition: |
Complete Standard.
Standard provides femoral component fatigue test methods with torsion and corresponding performance levels. Femoral components not meeting the performance levels specified in this standard need to justify not meeting the identified performance levels and/or may need clinical data to support their use. 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 |
| |
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, 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071275.htm |
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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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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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