University of Utah, Department of Orthopaedics · Class II · Cleared Apr 10, 2026
| K-number | K252699 |
| Device name | CoAptix S System |
| Applicant | University of Utah, Department of Orthopaedics |
| Product code | HWC |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The CoAptix S System is a metallic bone screw device intended for fixation of bone fractures, fusions, osteotomies, reconstructions, non-unions, and malunions in adults. The screws are available in multiple lengths and versions (headed and headless), are cannulated for guidewire-assisted placement, and include an optional washer.
The CoAptix S System uses similar design, materials, principles of operation, and size ranges as the predicate devices. It is manufactured from Ti-6Al-4V per ASTM F136 and Nitinol per ASTM F2063, available in cannulated configurations with headed and headless versions.
Testing performed per ASTM F543 (torsional strength, driving torque, axial pull-out), ASTM F1264 Annex A4 (static and dynamic bending), ASTM F2129 (pitting corrosion), ASTM G102 as referenced in ASTM F3044 (galvanic corrosion), fretting corrosion, and ASTM F2082 (Af testing).
The CoAptix S System is substantially equivalent to the DePuy Synthes Cortex and Cannulated Screws (K161616) and MedShape DynaFuse Fixation System (K203595) because it shares identical intended use, similar design and materials, and demonstrated equivalent or statistically significantly better performance in side-by-side testing.
View the full FDA submission: accessdata.fda.gov