Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-232: ISO 7207-1 Third edition 2007-02-01, Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions. (Orthopaedics)
Date of Standard: 2007. |
| 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: |
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| Processes Affected: |
| 510(k), HDE, IDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard except:
- For definitions of various Degrees of Constraint (e.g., ?constrained?, ?semi-constrained?, and ?non-constrained? joint prosthesis), please refer to 21 CFR 888.6.
- For definition of porous coated knee joint prosthesis, please reference ?Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.? In addition, the porous coating mean void intercept length (pore size) and volume percent void (% porosity) should be evaluated at distinct levels through the porous coating thickness using test methods described in Clause 9.4, ?Tissue Interface Gradient Method?, of ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants.
This standard provides classification, definitions, and designation of dimensions for partial and total knee joint prostheses.
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 may be needed 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, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3 |
NRA |
| Unclassified |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
Class 3 |
LXY |
| Unclassified |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3 |
MBD |
| Unclassified |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3 |
NJL |
| §888.3480 |
Prosthesis, Knee, Hinged (Metal-Metal) |
Class 3 |
HRZ |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis |
Class 3 |
KRN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented |
Class 2 |
KTX |
| §888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented |
Class 2 |
KMB |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KYK |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Class 2 |
KRO |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSX |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HRY |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3535 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
Class 2 |
NJD |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
KRR |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal |
Class 3 |
KRP |
| §888.3550 |
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer |
Class 2 |
KRQ |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
Class 2 |
MBV |
| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
Class 2 |
OIY |
| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Class 2 |
JWH |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 2 |
MBH |
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| Relevant Guidance: |
| Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, January 16, 2003 |
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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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