# K182789: KLS Martin Individual Patient Solutions (IPS) Planning System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Mar 11, 2019 after 161 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- 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 K924630 (1993). 11 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181241: KLS Martin Individual Patient Solutions (IPS) Planning System, KLS-Martin L.P. (2018) Summary page 4.

## Most influential descendants
- K192979: KLS Martin Individual Patient Solutions (IPS) Planning System (2020), 2 descendants of its own
- K243637: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (2025), 1 descendant of its own
- K211614: CenterMed Patient Matched Assisted Surgical Planning (ASP) System (2022), 1 descendant of its own
- K253308: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (2026), 0 descendants of its own
- K242263: TECHFIT DISRP® System (2024), 0 descendants of its own

## Indications for use
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system 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 Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Source page: https://510kreport.com/device/K182789
Methodology: https://510kreport.com/methodology