| ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| Recognition Number | Orthopedic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 11-272 |
| 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 guide describes a laboratory method using a weight-loss technique for evaluating the wear properties of materials or devices, or both, which are being considered for use as bearing surfaces of human-hip-joint replacement prostheses. The hip prostheses are evaluated in a device intended to simulate the tribological conditions encountered in the human hip joint, for example, use of a fluid such as bovine serum, or equivalent pseudosynovial fluid shown to simulate similar wear mechanisms and debris generation as found in vivo, and test frequencies of 1 Hz or less.
1.2 Since the hip simulator method permits the use of actual implant designs, materials, and physiological load/motion combinations, it can represent a more physiological simulation than basic wear-screening tests, such as pin-on-disk (see Practice F732) or ring-on-disk (see ISO 6474).
1.3 It is the intent of this guide to rank the combination of implant designs and materials with regard to material wear-rates, under simulated physiological conditions. It must be recognized, however, that there are many possible variations in the in vivo conditions, a single laboratory simulation with a fixed set of parameters may not be universally representative.
1.4 The reference materials for the comparative evaluation of candidate materials, new devices, or components, or a combination thereof, shall be the wear rate of extruded or compression-molded, ultra-high molecular weight (UHMW) polyethylene (see Specification F648) bearing against standard counter faces [stainless steel (see Specification F138); cobalt-chromium-molybdenum alloy (see Specification F75); thermomechanically processed cobalt chrome (see Specification F799); alumina ceramic (see Specification F603)], having typical prosthetic quality, surface finish, and geometry similar to those with established clinical history. These reference materials will be tested under the same wear conditions as the candidate materials.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3390 | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | KWY |
| §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 | 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, 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 |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class 2 | KWZ |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | Class 2 | PBI |
| There is no relevant guidance developed at this time. |