| ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| Recognition Number | Orthopedic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 11-342 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
| FDA Tech | Terry O. Woods FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2503 terry.woods@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup ("hip-type") wear, delamination wear, and so forth). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material.
1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests.
| 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 |
| §888.3670 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | MBF |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class 2 | KWS |
| §888.3650 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | KWT |
| §888.3565 | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class 2 | MBH |
| §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 |
| §888.3540 | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | KRR |
| §888.3530 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | HRY |
| §888.3520 | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class 2 | HSX |
| §888.3500 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite | Class 2 | KYK |
| §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 |
| §888.3410 | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer | Class 3 | KXB |
| §888.3410 | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented | Class 3 | OCG |
| §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 |
| §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, Calcium Phosphate | Class 2 | MEH |
| §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 |
| §888.3340 | Prosthesis, Hip, Semi-Constrained, Composite/Metal | Class 2 | KMC |
| §888.3160 | Prosthesis, Elbow, Semi-Constrained, Cemented | Class 2 | JDB |
| §888.3120 | Prosthesis, Ankle, Cemented, Non-Constrained | Class 3 | KXC |
| §888.3110 | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | HSN |
| §888.3100 | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite | Class 2 | KMD |
| 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 | LZJ | |
| Unclassified | Semi-Constrained Metal/Polymer Finger Joint Prosthesis | Class f | MPK |
| Guidance for Industry and FDA: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses, Issued January 2003 |