# K192279: PhantomMSK Trauma

- Pathway: 510(k) (Traditional)
- Applicant: OrthoGrid Systems, Inc.
- Decided: Dec 7, 2019 after 107 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182332: PhantomMSK, OrthoGrid Systems, Inc. (2019) Summary page 4.

## Indications for use
PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning Orthopedic Trauma components intraoperatively by measuring their positions relative to the bone structures of interest, provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device. The device is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K192279
Methodology: https://510kreport.com/methodology