# K212237: 3D-Cut

- Pathway: 510(k) (Traditional)
- Applicant: 3D-Side S.A.
- Decided: Nov 29, 2021 after 133 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K221943: EmbedMed (2023), 0 descendants of its own

## Indications for use
3D-Cut 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, including the resection of bone tumors, for femur, tibia and pelvis including sacrum.

Source page: https://510kreport.com/device/K212237
Methodology: https://510kreport.com/methodology