HipCheck

K230045

Stryker Corp. · cleared 2023-09-29 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility. . . . Stryker conducted standalone performance testing on an object detection AI/ML model that is a part of the image processing pipeline.”
Algorithmobject detection AI/ML model
source quote (p.10)
“Stryker conducted standalone performance testing on an object detection AI/ML model that is a part of the image processing pipeline.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (3)

Standalone

sample size not stated

endpoints: Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools.

Standalone

n=745 images · 6 site(s)

endpoints: Automatically detects the presence or absence of a hip; Finds the region of the image that contains the femur with high accuracy

Standalone

sample size not stated

endpoints: segmentation accuracy; reliability of segmentation; reliability of the HipMap FAI Analysis by comparing clinical measurement outputs

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230045