Dev4 · Class II · Cleared Jun 13, 2025
| K-number | K250251 |
| Device name | Eleganz Fusion Screw System (Fusion Screw System) |
| Applicant | Dev4 |
| Product code | HWC |
| Device class | Class II |
| Decision date | Jun 13, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Eleganz Fusion Screw System is a bone fixation device consisting of titanium alloy screws (solid and cannulated versions, 8-50 mm length) and associated instruments for screw site preparation and delivery. It is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation in bones appropriate for the device size, including carpal, metacarpal, phalangeal, and other small bone applications. The screws are not intended for interference or soft tissue fixation.
The Dev4 Eleganz screws have similar technological characteristics in design, material, and principle of operation as the predicate devices (Acutrak 3 Headless Compression Screw System and Cannulated Screw System). The screws are made from Ti6Al4V alloy, available in solid and cannulated versions ranging 8-50 mm in length with outer diameters from 2.5 mm to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The instrumentation includes drill, driver handle, driver bit, depth gauge, countersink, Kirschner wire, and ball and socket reamers.
Non-clinical testing was conducted in accordance with ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) and FDA Guidance on Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
The device demonstrates substantial equivalence because it does not raise different questions of safety and effectiveness compared to the predicate devices. The Eleganz screws share the same indications for use as the Acutrak 3 predicate and similar indications to the Cannulated Screw predicate. Non-clinical testing per established ASTM standards showed the device meets performance criteria comparable to the predicates. The similar design, material composition (Ti6Al4V), dimensions, and principle of operation as the predicates, combined with testing demonstrating equivalent performance characteristics, support that the device is substantially equivalent.
View the full FDA submission: accessdata.fda.gov