# K190044: VSP Orthopedics System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Aug 21, 2019 after 224 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K173167: SurgiCase Orthopedics System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K211244: VSP® Orthopedics System (2021), 6 descendants of its own
- K220717: RedPoint Medical's Better Bunion System (2022), 3 descendants of its own
- K241811: MedCAD® AccuStride™ System (2025), 2 descendants of its own
- K220706: MyPAO Guides (2023), 1 descendant of its own
- K212237: 3D-Cut (2021), 1 descendant 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/K190044
Methodology: https://510kreport.com/methodology