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Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated

by Johnson & Johnson Professionals, Inc.

510(k) K950010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 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)SN Traditional NumberK950010 Date15 May 1995DecidedStatusActive

Recalls

16 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-0385-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0418-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0388-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0395-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0387-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0420-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0419-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0393-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0389-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0390-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0392-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0386-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0391-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0421-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0422-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0394-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010

    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
SN

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