# K070786: X-Pod Adjustable Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Jun 28, 2007 after 98 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 2.
- K003155: Vertebral Body Replacement, Osteotech, Inc. (2001) Summary page 1.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 1.
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 2.

## Indications for use
The x.POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture). The x.POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation. The x.POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).

Source page: https://510kreport.com/device/K070786
Methodology: https://510kreport.com/methodology