Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-234: ASTM F732-00 (Reapproved 2011), Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses. (Orthopaedics)
Date of Standard: 2011. |
| 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: |
| Total Joint Prostheses with polymeric articulating surface |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| Vertical, National, Test Methods |
| Extent of Recognition: |
Complete standard
This standard is a test method for evaluating wear properties of materials that are being considered for use as bearing surfaces of total joint prostheses. This test method represents only an initial stage in the full wear characterization of a candidate material. The test method is used to screen material combinations for wear performance prior to further testing, such as in joint simulator apparatus.
Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| 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 |
| Unclassified |
Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented |
Class 3 |
MJT |
| Unclassified |
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained |
Class U |
LZJ |
| Unclassified |
Semi-Constrained Metal/Polymer Finger Joint Prosthesis |
Class f |
MPK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3100 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KMD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3120 |
Prosthesis, Ankle, Cemented, Non-Constrained |
Class 3 |
KXC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3160 |
Prosthesis, Elbow, Semi-Constrained, Cemented |
Class 2 |
JDB |
| |
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 |
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 |
| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer |
Class 3 |
KXB |
| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented |
Class 3 |
OCG |
| |
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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KYK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSX |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HRY |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
KRR |
| |
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 |
| |
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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
Class 2 |
KWT |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Class 2 |
KWS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
MBF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3800 |
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained |
Class 2 |
JWI |
| §888.3800 |
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
Class 2 |
JWJ |
| §888.3800 |
Prosthesis, Wrist, Semi-Constrained |
Class 2 |
KWM |
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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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