# K251863: CustomSurg OrthoPlanner

- Pathway: 510(k) (Traditional)
- Applicant: Customsurg AG
- Decided: Jul 7, 2025 after 20 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182464: PeekMed, Peek Health, S.A. (2018) Summary page 5.

## Indications for use
CustomSurg OrthoPlanner is a software system designed to help surgeons carry out pre-operative planning for surgical procedures, based on their patients’ imaging studies. The software imports diagnostic imaging studies such as x-rays and CT images. In parallel, there is a database of digital representations related to implant materials supplied by their producing companies. The software can process an imported 3D model of the patient’s CT scan to digitally perform the surgical planning. Experience in usage and a clinical assessment are necessary for proper use of the software. CustomSurg OrthoPlanner is to be used in conjunction with the planned device’s instructions for use, the patient’s clinical history, symptoms, and other pre-procedural evaluations by a surgeon who is responsible for making all final patient management decisions. It is not intended to replace the planned device’s instructions for use.

Source page: https://510kreport.com/device/K251863
Methodology: https://510kreport.com/methodology