# K210731: KLS Martin Individual Patient Solutions

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jul 18, 2022 after 494 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.
3 later devices descend from it; 3 cite it directly.
0 of 18 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
- 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 (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery. KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age to < 12 years of age), adolescents (12 years of age - 21 years of age), and adults.

Source page: https://510kreport.com/device/K210731
Methodology: https://510kreport.com/methodology