Foundation Knee Augmentation Blocks

• • 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

K941306 ↗

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 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

• Press-Fit Flared Shell

  Class II

  FDA 510(k) K960633 Active Cleared 1 Oct 1996

See all devices from Encore Orthopedics, Inc. →