# K050058: Theken Reveal VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical,Llc
- Decided: May 17, 2005 after 126 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: 6 generations back to K841189 (1984). 10 ancestors in all.
727 later devices descend from it; 7 cite it directly.
1 of 738 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 1.
- K022793: Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 1.
- K003155: Vertebral Body Replacement, Osteotech, Inc. (2001) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.

## Most influential descendants
- K080822: VU Apod Intervertabral Body Fusion Device (2008), 708 descendants of its own
- K112359: Prow Fusion (2011), 601 descendants of its own
- K130820: Expandable Lumbar Interbody System (2013), 593 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K101310: VU Apod Intervertebral Body Fusion Device (2010), 480 descendants of its own

## Indications for use
The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation. The Theken VU VBR SYSTEM is intended to be used 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/K050058
Methodology: https://510kreport.com/methodology