# K191028: KLS Martin Individual Patient Solutions

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Nov 22, 2019 after 218 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: 5 generations back to K954385 (1996). 13 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163579: KLS Martin Individual Patient Solutions, KLS Martin L.P. (2017) Summary page 4.

## Most influential descendants
- K210731: KLS Martin Individual Patient Solutions (2022), 3 descendants of its own
- K203282: TECHFIT Patient-Specific Maxillofacial System (2021), 1 descendant of its own
- K260137: KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions (2026), 0 descendants of its own
- K253206: METICULY Patient-specific CMF solution (2026), 0 descendants of its own
- K232350: Stryker Facial iD System (2024), 0 descendants of its own

## Indications for use
KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions.

Source page: https://510kreport.com/device/K191028
Methodology: https://510kreport.com/methodology