# K203282: TECHFIT Patient-Specific Maxillofacial System

- Pathway: 510(k) (Traditional)
- Applicant: Industrias Medicas Sampedro S.A.S
- Decided: May 19, 2021 after 194 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954385 (1996). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191028: KLS Martin Individual Patient Solutions, KLS-Martin L.P. (2019) Summary page 4.

## Most influential descendants
- K220199: AFFINITY Proximal Tibia System (2022), 0 descendants of its own

## Indications for use
TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.

Source page: https://510kreport.com/device/K203282
Methodology: https://510kreport.com/methodology