| ASTM F1781-15 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 11-305 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
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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 elastomeric flexible hinge finger total joint implants, used with and without metal grommets in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.
1.2 This specification excludes those implants that do not have an across-the-joint elastomeric linkage. The specification is limited to implants made from one material in a single one-step molding procedure.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3230 | Prosthesis, Finger, Constrained, Polymer | Class 2 | KYJ |
| §888.3230 | Prosthesis, Finger, Polymer | Class 2 | KWF |
| There is no relevant guidance developed at this time. |