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Journey 74035892

by Smith & Nephew, Inc.

Journey 74035892 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K190085 on 11 Feb 2019 and listed in FDA GUDID since 13 Jun 2019 (UDI-DI 00885556690925), 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

1 ongoing

This device is named in the recall

Documents

510(k) K190085

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 Number00885556690925 UDI-DI Date13 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK190085 Date11 Feb 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190085 decided 11 Feb 2019 Active
  • FDA GUDID UDI-DI 00885556690925 listed 13 Jun 2019 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1393-2023 FDA Class II initiated 27 Mar 2023

    A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

  • 2 recalls, same reason

    • Terminated Z-2133-2020 FDA Class II initiated 28 Jan 2020
    • Terminated Z-2132-2020 FDA Class II initiated 28 Jan 2020

    The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

Timeline

5 dated events

  1. Cleared FDA 510(k) K190085
  2. Listed FDA GUDID 00885556690925
  3. Recall initiated FDA recalls Z-2133-2020
  4. Recall initiated FDA recalls Z-2132-2020
  5. Recall initiated FDA recalls Z-1393-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Journey
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
74035892
Description
JOURNEY II UK LEFT LATERAL TIBIA TRIAL SIZE 2
Primary DI / UDI-DI
00885556690925
510(k) Number
FDA product code
HSX
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class II
Regulation number
888.3520
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 (K190085)

and 8 more cleared under K190085

Similar devices in this category

Other devices filed under Knee tibia prosthesis trial, reusable.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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