VSP Orthopedics System
FDA 510(k) K250711 · 3D Systems, Inc.
510(k) numberK250711
Submission
- Device name
- VSP Orthopedics System
- Applicant
- 3D Systems, Inc.
Littleton, CO, US - Received
- March 10, 2025
- Decision date
- December 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBF – Orthopaedic Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
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More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 06/03/2026SE |
| K243174 | Cadence Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K243173 | Salto Talaris Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 04/04/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 06/30/2023SE |
| K214093 | VSP BolusIXI · Traditional | 03/30/2022SE |
| K211244 | VSP® Orthopedics SystemPBF · Traditional | 11/10/2021SE |
| K210347 | VSP SystemDZJ · Traditional | 04/26/2021SE |
Questions and answers
When was VSP Orthopedics System cleared by the FDA?
VSP Orthopedics System (K250711) received a 510(k) decision of Substantially Equivalent on December 5, 2025, 270 days after the submission was received.
What is the product code of K250711?
The FDA product code is PBF – Orthopaedic Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 888.3030.