Foundation Knee System Tibial Component

• • Terminated Z-0349-2012 FDA Unclassified (pre-2012) ·initiated 26 Oct 2011

  The strike plate may dislodge from the broach stem handle during impaction of the device.

• • 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.

510(k) Number

K970031 ↗

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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