| K-number | K250711 |
| Device name | VSP Orthopedics System |
| Applicant | 3D Systems, Inc. |
| Product code | PBF |
| Device class | Class II |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The VSP Orthopedics System is a surgical planning and guidance system that assists orthopedic surgeons with preoperative planning and intraoperative guidance for non-acute, non-joint-replacing bone procedures (osteotomies) in the distal femur, tibia, and non-sacrum pelvis. It produces patient-specific anatomical models, templates, guides, and surgical plans designed with physician input, plus stainless steel drill inserts to guide drilling during surgery.
The subject device has identical technological characteristics to the predicate device, including the same design, materials, chemical composition, and principle of operation. No changes to the underlying technology were made in this submission.
Not stated in this summary.
Substantial equivalence is established because the device has unchanged technological characteristics compared to the predicate (K211244), the intended use remains identical, and clinical data from systematic literature review and Compassionate Use cases support safety and effectiveness in the expanded pediatric population (skeletally mature adolescents). The only modification is an expansion of indications to include pediatric use, which is supported by existing clinical evidence.
View the full FDA submission: accessdata.fda.gov