| ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-341 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
| FDA Tech | John Goode FDA/OMPT/CDRH/ODE/DOD/JFDB2/ 301-796-6407 john.goode@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 covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.
1.3 This test method may require modifications to accommodate other tibial tray designs.
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported midsection of the condyle.
| 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 |
| §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 |
| Guidance for Industry and FDA: Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses, Issued January 2003 |