# K250711: VSP Orthopedics System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Dec 5, 2025 after 270 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K190044 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211244: VSP® Orthopedics System, 3D Systems (2021) Summary page 5.

## Indications for use
The VSP Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies in the distal femur, tibia, and non-sacrum pelvis of adults and skeletally mature adolescents of normal stature.

Source page: https://510kreport.com/device/K250711
Methodology: https://510kreport.com/methodology