Vks Knee System

• • Terminated Z-0361-2008 FDA Unclassified (pre-2012) ·initiated 13 Nov 2006

  Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.

• • Terminated Z-0397-06 FDA Unclassified (pre-2012) ·initiated 2 Dec 2005

  The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

• • Terminated Z-0924-05 FDA Unclassified (pre-2012) ·initiated 3 Jun 2005

  Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.

• • Terminated Z-0540-05 FDA Unclassified (pre-2012) ·initiated 4 Jan 2005

  Knee tibial insert is mislabeled completely as different device.

510(k) Number

K022204 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

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