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Instrument 5531-T-116Y

by Howmedica Osteonics Corp.

Instrument 5531-T-116Y is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K173849 on 2 Feb 2018 and listed in FDA GUDID since 21 Dec 2018 (UDI-DI 07613327403756), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K173849

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327403756 UDI-DI Date21 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173849 Date2 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173849 decided 2 Feb 2018 Active
  • FDA GUDID UDI-DI 07613327403756 listed 21 Dec 2018 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1260-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1259-2024 FDA Class II initiated 6 Feb 2024

    Potential packaging breaches of inner blister and outer sterile blister.

    • Ongoing Z-1653-2023 FDA Class II initiated 13 Apr 2023

    Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Timeline

5 dated events

  1. Cleared FDA 510(k) K173849
  2. Listed FDA GUDID 07613327403756
  3. Recall initiated FDA recalls Z-1653-2023
  4. Recall initiated FDA recalls Z-1260-2024
  5. Recall initiated FDA recalls Z-1259-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Instrument
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
5531-T-116Y
Primary DI / UDI-DI
07613327403756
510(k) Number
FDA product code
JWH, MBH
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class II
Regulation number
888.3560, 888.3565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K173849)

and 8 more cleared under K173849

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)