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Tc-Plus Primary Knee System

by Smith & Nephew, Inc.

510(k) K072858

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 · Abbreviated NumberK072858 Date20 Nov 2007ClearedStatusActive

Official records

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-1544-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1539-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1538-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1547-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1546-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1551-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1537-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1540-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1545-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1549-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1542-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1550-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1543-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1548-2016 FDA Class II initiated 11 Mar 2016
    • Terminated Z-1541-2016 FDA Class II initiated 11 Mar 2016

    The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

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  • Withdrawn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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