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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

    K041216

    Cited as predicate by: K121861, K132357

    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
    2025-01-27NAINo action indicatedIntegrity Orthopaedics Inc0
    2023-05-03NAINo action indicatedCARTIHEAL, LTD0
    2021-12-09VAIVoluntary action indicatedSmith & Nephew, Inc.1
    2021-12-09VAIVoluntary action indicatedSmith & Nephew, Inc.1
    2021-10-26NAINo action indicatedSmith & Nephew Inc.0
    2021-10-26NAINo action indicatedSmith & Nephew Inc.0
    2020-02-06VAIVoluntary action indicatedBlue Belt Technologies, Inc6
    2019-10-25NAINo action indicatedTusker Medical, Inc.0
    2019-10-08VAIVoluntary action indicatedTusker Medical, Inc.3
    2018-03-30NAINo action indicatedAscension Orthopedics, Inc0
    2018-02-02NAINo action indicatedSmith & Nephew, Inc.0
    2018-02-02NAINo action indicatedSmith & Nephew, Inc.0
    2018-01-30NAINo action indicatedSmith & Nephew0
    2017-08-21NAINo action indicatedSmith & Nephew, Inc. Advanced Surgical Devices Division0
    2017-08-02VAIVoluntary action indicatedSmith & Nephew, Inc.3
    2017-08-02VAIVoluntary action indicatedSmith & Nephew, Inc.3
    2017-07-24NAINo action indicatedSmith & Nephew, Inc.0
    2017-07-24NAINo action indicatedSmith & Nephew, Inc.0
    2017-05-25NAINo action indicatedSmith & Nephew, Inc.0
    2017-05-25NAINo action indicatedSmith & Nephew, Inc.0
    2015-04-30WLWarning LetterSmith & Nephew Inc.—
    2015-04-30WLWarning LetterSmith & Nephew Inc.—
    2014-06-11WLWarning LetterSmith & Nephew, Inc.—
    2010-09-16WLWarning LetterAscension Orthopedics, Inc—
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