Skip to content

Salto XT, Salto Talaris

by Tornier S.A.S.

510(k) K153452

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK153452 Date11 Aug 2016ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1172-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1169-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1175-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1174-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1170-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1168-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1173-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1171-2019 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

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  • Withdrawn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

Other devices from Tornier S.A.S.

See all devices from Tornier S.A.S. →