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JOURNEY II XR Knee Instruments

by Smith & Nephew, Inc.

510(k) K173331

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK173331 Date16 Nov 2017ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1044-2019 FDA Class II initiated 10 Dec 2018
    • Terminated Z-1042-2019 FDA Class II initiated 10 Dec 2018
    • Terminated Z-1043-2019 FDA Class II initiated 10 Dec 2018
    • Terminated Z-1045-2019 FDA Class II initiated 10 Dec 2018

    Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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