# K071031: VU E*Pod Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Jul 30, 2007 after 110 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). 11 ancestors in all.
119 later devices descend from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have 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.
- K050058: Theken Reveal VBR System, Theken Surgical,Llc (2005) Summary page 1.

## Most influential descendants
- K082712: Theken Spine VU Epod and VU Lpod System (2009), 118 descendants of its own
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene (2014), 116 descendants of its own
- K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene (2016), 103 descendants of its own
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System (2017), 82 descendants of its own
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device (2016), 79 descendants of its own

## Indications for use
The Vu e*POD Vertebral Body Replacement is indicated for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture). The Vu e.POD Vertebral Body Replacement is designed to restore the bionmechanical 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 Vu e*POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical, LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).

Source page: https://510kreport.com/device/K071031
Methodology: https://510kreport.com/methodology