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Synthes Reamer/Irrigator/Aspirator (Ria) System

by Synthes (Usa)

510(k) K993335

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993335 Date12 Jun 2000ClearedStatusActive

Recalls

17 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-0573-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0571-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0574-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0577-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0581-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0580-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0585-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0586-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0575-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0576-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0582-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0587-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0583-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0584-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0572-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0578-2021 FDA Class II initiated 19 Nov 2020
    • Terminated Z-0579-2021 FDA Class II initiated 19 Nov 2020

    RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HTO
Device Class
Class I
Regulation
21 CFR Part 888.4540
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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