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TC-PLUS Primary 75000336

by Smith & Nephew, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 closed

Documents

510(k) K072858

FDA submission, from GUDID

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 Number07611996094152 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK072858 Date20 Nov 2007DecidedStatusActive

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  • Withdrawn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

GUDID

Trade name
TC-PLUS Primary
Generic name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
75000336
Primary DI / UDI-DI
07611996094152
510(k) Number
FDA product code
JWH
GMDN term
Uncoated knee tibia prosthesis, polyethylene
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K072858)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • 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