# K182332: PhantomMSK

- Pathway: 510(k) (Traditional)
- Applicant: OrthoGrid Systems, Inc.
- Decided: Feb 15, 2019 after 171 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: 10 generations back to K896095 (1990). 25 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160284: JointPoint, Jointpoint, Inc. (2016) Summary page 4.

## Most influential descendants
- K210136: PhantomMSK Hip (2021), 3 descendants of its own
- K260077: OrthoGrid Hip AI® 4.0 (2026), 0 descendants of its own
- K260321: HipGuide (V 1.0.0.0) (2026), 0 descendants of its own
- K252214: AIAS Cephalon (2025), 0 descendants of its own
- K192279: PhantomMSK Trauma (2019), 0 descendants of its own

## Indications for use
PhantomMSK is an image-processing software indicated to assist in the positioning of Total Hip Replacement components. It is intended to assist in precisely positioning Total Hip Replacement 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/K182332
Methodology: https://510kreport.com/methodology