Foundation Knee System

• • Terminated Z-2466-2008 FDA Unclassified (pre-2012) ·initiated 4 Aug 2008

  Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.

• • Terminated Z-0331-06 FDA Unclassified (pre-2012) ·initiated 3 Nov 2005

  The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

• • Terminated Z-1010-04 FDA Unclassified (pre-2012) ·initiated 10 May 2004

  Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

• • Terminated Z-1069-03 FDA Unclassified (pre-2012) ·initiated 24 Apr 2003

  Product container was labeled incorrectly indicating left femur instead of right.

510(k) Number

K923277 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

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