# K180962: KLS Martin Individual Patient Solutions

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 13, 2018 after 123 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.
No later device cites it as a predicate yet.
0 of 14 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.
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 4.

## 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/K180962
Methodology: https://510kreport.com/methodology