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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-09-19Z-0145-2026Class IIOpen, ClassifiedComplaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.Distribution: US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.21 systemsclearance family
Regulatory clearances
  • 510(k)K243950Substantially equivalent (SESE) · 2025-01-13clearance family

Predicate lineage

Cited as predicate by: K243950

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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