# K250290: SurgiTwin

- Pathway: 510(k) (Traditional)
- Applicant: Twinsight
- Decided: Aug 29, 2025 after 210 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: 11 generations back to K896095 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240926: PeekMed web, Peek Health, S.A. (2024) Summary page 5.

## Indications for use
SurgiTwin is a web-based platform designed to help healthcare professionals carry out pre-operative planning for knee reconstruction procedures, based on their patients' imported imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The system works with a database of digital representations related to surgical materials supplied by their manufacturers. SurgiTwin generates a PDF report as an output. End users of the generated SurgiTwin reports are trained healthcare professionals. SurgiTwin does not provide a diagnosis or surgical recommendation.

Source page: https://510kreport.com/device/K250290
Methodology: https://510kreport.com/methodology