Skip to content

Advance Total Knee System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K061223

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK061223 Date18 Aug 2006ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

13 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-2696-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2695-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2697-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2701-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2703-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2698-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2702-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2694-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2699-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2693-2016 FDA Class I initiated 21 Jun 2016
    • Terminated Z-2700-2016 FDA Class I initiated 21 Jun 2016

    ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.

  • 2 recalls, same reason

    • Terminated Z-0492-2010 FDA Unclassified (pre-2012) initiated 22 Sep 2009
    • Terminated Z-0493-2010 FDA Unclassified (pre-2012) initiated 22 Sep 2009

    Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.

Specification

510(k)

510(k) Number
FDA Product Code
MBH
Device Class
Class II
Regulation
21 CFR Part 888.3565
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Wrightmedicaltechnologyinc

See all devices from Wrightmedicaltechnologyinc →