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Natural-Knee II Cemented Modular Tibial Baseplate

by Centerplus Orthopedics, Inc.

510(k) K023528

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 · Traditional NumberK023528 Date17 Jan 2003ClearedStatusActive

Recalls

5 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1482-2009 FDA Unclassified (pre-2012) initiated 18 Mar 2009
    • Terminated Z-1484-2009 FDA Unclassified (pre-2012) initiated 18 Mar 2009
    • Terminated Z-1485-2009 FDA Unclassified (pre-2012) initiated 18 Mar 2009
    • Terminated Z-1483-2009 FDA Unclassified (pre-2012) initiated 18 Mar 2009

    The tibial spacer will not affix to the distal surface of the baseplate, as intended.

    • Terminated Z-0871-2009 FDA Unclassified (pre-2012) initiated 25 Nov 2008

    Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.

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  • Withdrawn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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