Theken Cpod/Lpod Vertebral Body Replacement System

• • Terminated Z-2202-2011 FDA Unclassified (pre-2012) ·initiated 18 Jan 2011

  Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.

510(k) Number

K032064 ↗

FDA Product Code

MQP

FDA applicant

Theken Surgical,Llc

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Dogbone Acfs

  Class II

  FDA 510(k) K994383 Active Cleared 4 Feb 2000

• Theken Small Cement Restrictor

  Class II

  FDA 510(k) K012278 Active Cleared 17 Oct 2001

• Theken Reveal Vbr System

  Class II

  FDA 510(k) K050058 Active Cleared 17 May 2005

• Tether Acfs

  Class II

  FDA 510(k) K010466 Active Cleared 16 May 2001

• Bodyform Thoraco-Lumbar Fixation System

  Class II

  FDA 510(k) K983622 Active Cleared 30 Dec 1998

• Nonlinear Taper Lag Screw

  Class II

  FDA 510(k) K994382 Active Cleared 10 Mar 2000

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