| ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-310 |
| 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 provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone.
1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.4540 | Reamer | Class 1 | HTO |
| §888.3020 | Rod, Fixation, Intramedullary And Accessories | Class 2 | HSB |
| Reviewers Guidance Checklist For Intramedullary Rods version #4, Issued February 1997. |