# K260321: HipGuide (V 1.0.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Driven Imaging, LLC
- Decided: May 8, 2026 after 98 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: 12 generations back to K896095 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210136: PhantomMSK Hip, OrthoGrid Systems, Inc. (2021) Summary page 5.

## Indications for use
HipGuide is a medical device software application designed to assist surgeons in evaluating implant positioning, alignment, and anatomical relationships during hip replacement procedures. HipGuide supports intra-operative clinical decision making by providing visual overlays or measurements taken manually on fluoroscopic images. It is not intended to replace the surgeon’s judgment or serve as a diagnostic device. Rx only.

Source page: https://510kreport.com/device/K260321
Methodology: https://510kreport.com/methodology