| ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-339 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.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.
This part of ISO 7206 specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows:
a) sphericity and surface finish requirements for metallic and ceramic femoral prostheses for partial hip joint replacement that are in accordance with classification a) of ISO 7206-1;
b) sphericity and surface finish requirements for bipolar heads with plastics inner surfaces which articulate on femoral components that are in accordance with classification a) of ISO 7206-1 and with metallic or ceramic outer surfaces which articulate on the biological acetabulum;
c) sphericity and surface finish requirements and dimensional tolerances for plastics acetabular components that are in accordance with classification b) of ISO 7206-1;
d) sphericity and surface finish requirements and dimensional tolerances for metallic or ceramic femoral components of total hip joint prostheses that are in accordance with classification c) of ISO 7206-1, designed to articulate on plastics acetabular components.
| 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 |
| §888.3390 | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | KWY |
| §888.3360 | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class 2 | JDG |
| §888.3360 | Prosthesis, Hip, Hemi-, Femoral, Metal | Class 2 | KWL |
| §888.3360 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | LWJ |
| §888.3360 | Prosthesis, Upper Femoral | Class 2 | JDD |
| §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 |
| §888.3330 | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Class 3 | KWA |
| §888.3320 | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Class 3 | JDL |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class 2 | KWZ |
| §888.3300 | Prosthesis, Hip, Constrained, Metal | Class 3 | KXD |
| Unclassified | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | Class 3 | LPF |
| Unclassified | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Class 3 | MRA |
| Unclassified | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | Class 3 | NXT |
| Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, Issued January 1995 |