| ASTM F2887-17 Standard Specification for Total Elbow Prostheses |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 11-321 |
| 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 total elbow replacement (TER) prostheses and hemi-elbow replacement ("hemi") prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.
1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device will provide satisfactory clinical performance.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3180 | Prosthesis, Elbow, Hemi-, Humeral, Metal | Class 3 | KWJ |
| §888.3170 | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class 2 | KWI |
| §888.3160 | Prosthesis, Elbow, Semi-Constrained, Cemented | Class 2 | JDB |
| §888.3150 | Prosthesis, Elbow, Constrained, Cemented | Class 2 | JDC |
| There is no relevant guidance developed at this time. |