# K201052: KLS Martin Individual Patient Solutions (IPS) Planning System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 31, 2020 after 132 days
- Product code: PPT (Cranial Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182889: KLS Martin Individual Patient Solutions (IPS) Planning System, KLS-Martin L.P. (2019) Summary page 4.

## 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 computerized tomography (CT) medical scan. 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, and case reports for use in the marking and cutting of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider’s judgment and analysis of the patient’s condition.

Source page: https://510kreport.com/device/K201052
Methodology: https://510kreport.com/methodology