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FDA-cleared K230045

HipCheck

Stryker Corp.

Authorized purpose: HipCheck assists surgeons with quantitative measurements for femoroacetabular-impingement procedures by processing intraoperative static fluoroscopic images and superimposing virtual measurement tools for skeletally mature patients. HipMap FAI Analysis provides a patient-specific report for surgeon or radiologist preoperative decision-making with morphological measurements and visualizations of hip impingement and stability.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip; femoral head and neck; femoroacetabular impingement
Decision
2023-09-29