| K-number | K253517 |
| Device name | Reselute Tibial Nail |
| Applicant | Reselute, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Mar 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Reselute Tibial Intramedullary Nail is a single-use titanium alloy device designed to stabilize fractures of the proximal and distal tibia and tibial shaft. It includes a nail of various diameters and lengths, cross-locking screws to prevent nail movement relative to bone fragments, and optional endcaps to prevent proximal bone ingrowth.
The device is manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136-13 and is provided with locking screws and endcaps. It matches the primary predicate (GPC Intramedullary Nailing Systems K143245) in material composition, design, product features, and mechanical performance characteristics.
Static bending (ASTM F1264-16), static torsion (ASTM F1264-16), dynamic bending (ASTM F1264-16), dynamic screw bending (ASTM F1264-16), metallic bone screw testing (ASTM F543-23), and MR testing (ASTM F2052, F2213, F2182, F2119).
The Reselute Tibial Nail is substantially equivalent to the GPC Intramedullary Nailing Systems predicate because it shares identical intended use and indications for use, is manufactured from the same material, has similar design and technological characteristics, and demonstrates equivalent mechanical performance in non-clinical testing with no new safety or efficacy concerns.
View the full FDA submission: accessdata.fda.gov