Foundation Modular Tibial Baseplate

• • Terminated Z-0826-2010 FDA Unclassified (pre-2012) ·initiated 11 Dec 2009

  Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.

• • Terminated Z-0622-2010 FDA Unclassified (pre-2012) ·initiated 3 Dec 2009

  Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate.

510(k) Number

K932425 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• 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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