# 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

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 17, 2026 after 213 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: 8 generations back to K904436 (1990). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210731: KLS Martin Individual Patient Solutions, KLS-Martin L.P. (2022) Summary page 4.
- K062570: Patient Contoured Mesh (PCM), KLS-Martin L.P. (2006) Summary page 4.
- K072707: Patient Contoured Mesh-Peek (PCM-P), KLS-Martin L.P. (2007) Summary page 4.
- K241314: KLS Martin Oral-Max Implants MR Conditional (bundled), KLS-Martin L.P. (2024) Summary page 5.

## Indications for use
Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton. Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton. 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/K260137
Methodology: https://510kreport.com/methodology