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Salto Talaris Total Ankle Prosthesis, Rhs

by Tornier S.A.S.

510(k) K130533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

19 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 · Special NumberK130533 Date17 May 2013ClearedStatusActive

Recalls

19 recalls · FDA

  • 18 recalls, same reason

    • Terminated Z-1161-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1164-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1151-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1167-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1163-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1162-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1166-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1152-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1155-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1153-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1165-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1150-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1158-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1156-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1157-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1159-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1154-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1160-2019 FDA Class II initiated 8 Mar 2019

    The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

    • Terminated Z-2465-2015 FDA Class II initiated 6 Aug 2015

    Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.

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  • Withdrawn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
HSN
Device Class
Class II
Regulation
21 CFR Part 888.3110
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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