Skeletal Dynamics, Inc. · Class II · Cleared Mar 23, 2026
| K-number | K254288 |
| Device name | Clavicle Fixation System |
| Applicant | Skeletal Dynamics, Inc. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Mar 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Clavicle Fixation System is a surgical device made of titanium and cobalt-chromium metal plates and screws in various sizes (2.5mm, 2.7mm, 3.5mm) designed to repair clavicle fractures, osteotomies, and non-unions, including in osteopenic bone. The system includes pegs that accept orthogonal screws, K-wires, and specialized instruments, and is provided non-sterile for user sterilization.
The device differs from the predicate A.L.P.S. Clavicle Plating System through variations in plate geometry and screw design. A key addition is the incorporation of pegs used with targeting guide instruments to facilitate orthogonal screw placement. Despite these differences, mechanical performance testing shows the subject device meets or exceeds the performance of the predicate device.
Static and dynamic plate testing was conducted per ASTM F382-24. Screw testing including driving torque, torsional yield strength, and axial pullout strength was performed per ASTM F543-23. Additional non-standard testing evaluated the mechanical performance of the peg and screw interface under rotational and axial loading conditions.
View the full FDA submission: accessdata.fda.gov