| ASTM F1378-17 Standard Specification for Shoulder Prostheses |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-328 |
| 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 specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components.
1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3690 | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class 2 | HSD |
| §888.3680 | Metallic Cemented Glenoid Hemi-Shoulder Prosthesis | Class 3 | KYM |
| §888.3670 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | MBF |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class 2 | PAO |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class 2 | KWS |
| §888.3650 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | KWT |
| §888.3640 | Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented | Class 3 | KWR |
| Unclassified | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | Class 3 | MJT |
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis, Issued October 2000 |