# K211244: VSP® Orthopedics System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems
- Decided: Nov 10, 2021 after 198 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: 1 generation back to K190044 (2019). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190044: VSP Orthopedics System, 3D Systems, Inc. (2019) Summary page 4.

## Most influential descendants
- K220717: RedPoint Medical's Better Bunion System (2022), 3 descendants of its own
- K241811: MedCAD® AccuStride™ System (2025), 2 descendants of its own
- K252064: MedCAD® AccuStride™ System (2026), 0 descendants of its own
- K250711: VSP Orthopedics System (2025), 0 descendants of its own
- K251709: MedCAD® AccuStride™ System (2025), 0 descendants of its own

## 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 for adult patients in the distal femur, tibia, and non-sacrum pelvis.

Source page: https://510kreport.com/device/K211244
Methodology: https://510kreport.com/methodology