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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

    K060874

    Cited as predicate by: K123814, K130759, K203230

    K992065

    Cited as predicate by: K093599, K103835, K170910, K203230, K212683

    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
    2024-03-28NAINo action indicatedDePuy Orthopaedics, Inc.0
    2022-05-12NAINo action indicatedDePuy Orthopaedics, Inc.0
    2019-11-08NAINo action indicatedDePuy Orthopaedics, Inc.0
    2017-09-01VAIVoluntary action indicatedDePuy Orthopaedics, Inc.2
    2015-10-01VAIVoluntary action indicatedDePuy Orthopaedics, Inc.2
    2015-09-24NAINo action indicatedDePuy Orthopaedics, Inc.0
    2012-11-26VAIVoluntary action indicatedDePuy Orthopaedics, Inc.6
    2011-12-08WLWarning LetterDePuy Orthopaedics, Inc.—
    2011-08-16NAINo action indicatedDePuy Orthopaedics, Inc.0
    2011-06-07OAIOfficial action indicatedDePuy Orthopaedics, Inc.6
    2010-08-19WLWarning LetterDePuy Orthopaedics, Inc.—
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