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Salto Talaris® LJU288T

by Ascension Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

18 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780366089 UDI-DI Date3 May 2017ListedStatusListed GUDID: in commercial distribution

Recalls

18 recalls · FDA

  • 18 recalls, same reason

    • 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
    • Terminated Z-1161-2019 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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Salto Talaris®
Generic Name
Fixed-bearing total ankle prosthesis
Model / Reference
LJU288T
Primary DI / UDI-DI
10381780366089
510(k) Number
FDA Product Code
HSN
GMDN Term
Fixed-bearing total ankle prosthesis
Device Class
Class II
Regulation Number
888.3110
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fixed-bearing total ankle prosthesis

Cleared under the same submission (K060544)

Show all (12)

Other devices from Ascension Orthopedics, Inc.

See all devices from Ascension Orthopedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No