# K163579: KLS Martin Individual Patient Solutions

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Nov 21, 2017 after 336 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: 4 generations back to K954385 (1996). 12 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 4.

## Most influential descendants
- K191028: KLS Martin Individual Patient Solutions (2019), 7 descendants of its own
- 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

## Indications for use
KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

Source page: https://510kreport.com/device/K163579
Methodology: https://510kreport.com/methodology