Synthes GmbH · Class II · Cleared Mar 9, 2026
| K-number | K260069 |
| Device name | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System |
| Applicant | Synthes GmbH |
| Product code | HRS |
| Device class | Class II |
| Decision date | Mar 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System is a set of stainless steel orthopedic plates with variable angle screw holes designed for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) with fused growth plates. The system includes five families of contoured plates available in various lengths, along with non-implantable accessories such as guide blocks, sizing templates, and trays.
The subject device comprises 3.5-mm contoured stainless steel plates with variable angle screw holes, available in multiple lengths and configurations (standard and long plates). The device is similar in material composition and fundamental design to predicate devices, with technological differences that do not raise new safety or effectiveness concerns.
Not stated in this summary.
The subject devices share the same intended use and similar indications as the predicate devices and are metallic orthopedic plates for bone fracture fixation made from the same material. Computational finite element analysis demonstrated the subject plates were non-inferior in bending moment and stiffness, and MR conditional parameters were established, demonstrating that differences in technological characteristics do not raise new questions of safety and effectiveness.
View the full FDA submission: accessdata.fda.gov