# K070381: Theken VU Mesh VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Apr 25, 2007 after 76 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K841189 (1984). 14 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050058: Theken Reveal VBR System, Theken Surgical,Llc (2005) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 1.
- K032371: Titanium Mesh System, Encore Medical L.P. (2004) Summary page 1.
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.

## Most influential descendants
- K111294: Santorini Spinal System (2012), 18 descendants of its own
- K142016: CAPRI (2014), 12 descendants of its own
- K170055: CAPRI Corpectomy Cage System (2017), 11 descendants of its own
- K171704: CAPRI Corpectomy Cage System (2017), 10 descendants of its own
- K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System (2018), 9 descendants of its own

## Indications for use
The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (Ti -L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture). The Theken VU MESH VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation. The Theken VU MESH VBR SYSTEM is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

Source page: https://510kreport.com/device/K070381
Methodology: https://510kreport.com/methodology