# K182359: HipCheck

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Dec 13, 2018 after 105 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 K911783 (1994). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132636: Dyonics Plan Hip Impingement Planning System, Smith & Nephew, Inc. (2013) Summary page 4.
- K103400: Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip, Stryker Corporation (2011) Summary page 4.

## Most influential descendants
- K230045: HipCheck (2023), 0 descendants of its own

## Indications for use
HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images. HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.

Source page: https://510kreport.com/device/K182359
Methodology: https://510kreport.com/methodology