# K230045: HipCheck

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Sep 29, 2023 after 266 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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 K911783 (1994). 46 ancestors in all.
No later device cites it as a predicate yet.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182359: HipCheck, Stryker Corp. (2018) Summary page 4.

## Indications for use
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients. HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist pre-operative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.

Source page: https://510kreport.com/device/K230045
Methodology: https://510kreport.com/methodology