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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

No recalls linked.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K172326, K180612, K220930, K242831

    Cited as predicate by: K252898, K253637

    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
    DateTypeOutcomeFacilityCitations
    2018-02-23VAIVoluntary action indicatedMako Surgical Corporation2
    2014-11-25NAINo action indicatedMako Surgical Corporation0
    2014-08-11VAIVoluntary action indicatedMako Surgical Corporation3
    2013-02-26VAIVoluntary action indicatedMako Surgical Corporation2
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