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P.F.C. Cruciate Retaining Knee System (Size 1.5)

by Johnson & Johnson Professionals, Inc.

510(k) K961685

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK961685 Date10 Jul 1996ClearedStatusActive

Recalls

7 recalls · FDA

    • Terminated Z-0057-2007 FDA Unclassified (pre-2012) initiated 14 Sep 2006

    Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

  • 6 recalls, same reason

    • Terminated Z-1315-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1317-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1320-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1316-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1319-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1318-05 FDA Unclassified (pre-2012) initiated 26 May 2005

    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.

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  • Withdrawn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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