Synthes GmbH · Class unclassified · Cleared Mar 10, 2026
| K-number | K254093 |
| Device name | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System |
| Applicant | Synthes GmbH |
| Product code | — |
| Device class | Class unclassified |
| Decision date | Mar 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is an implantable device consisting of 3.5mm anatomic medial distal femur plates made of stainless steel with variable angle screw holes. It is indicated for internal fixation of isolated medial condylar fractures as standalone fixation and as an adjunct for other distal femur fractures, corrective osteotomies, non-unions, and malunions in adults and adolescents aged 12-21 years with fused or non-compromised growth plates.
The subject device is an iteration on prior DePuy Synthes plating systems with similar design, material, and fundamental technology as the predicate devices. It features 3.5mm anatomic medial distal femur plates with variable angle screw holes and accepts VOLT™ stainless steel screws including 3.5mm locking, 3.5mm cortical, and 4.0mm cancellous screws.
Not stated in this summary. The document references computational finite element analysis and magnetic resonance compatibility testing but does not cite specific ISO, IEC, or ASTM standards by designation.
The subject devices have the same intended use and similar indications as their predicate devices. Computational finite element analysis demonstrated non-inferiority in yield load, and magnetic resonance compatibility testing established MR Conditional parameters. The non-clinical performance data and analytic evaluations demonstrate that differences in technological characteristics do not raise new questions of safety and effectiveness, making the devices at least as safe and effective as the predicates.
View the full FDA submission: accessdata.fda.gov