VELYS Hip Navigation
K253551Depuy Ireland UC · cleared 2026-03-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“VELYS™ Hip Navigation (VHN) is a Software as a Medical Device that provides the clinician with intra-operative measurements and visuals of acetabular cup orientation, femoral component leg length and offset calculations, and implant constructs based on userdefined, but machine learning (ML) default-positioned, bony-anatomy landmark points.”
source quote (p.6)
“VHN includes a machine learning model that places the default position of the landmark based on the output of the model; the user has full control to manipulate the landmark positions after placement.”
Validation studies (2)
Standalone
n=18,550 images
endpoints: mAR (mean Average Recall); mAP (mean Average Precision); mAP@0.75
Bench
sample size not stated
endpoints: leg length; femoral offset; total offset; cup inclination; cup anteversion; Workflow Efficiency
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
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).