# K172323: Omnia Medical VBR

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Oct 26, 2017 after 86 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: 8 generations back to K841189 (1984). 15 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070381: Theken VU Mesh VBR System, Theken Spine, LLC (2007) Summary page 4.

## Most influential descendants
- K191778: Omnia Medical VBR (2019), 5 descendants of its own
- K202637: F3D Corpectomy System (2020), 1 descendant of its own
- K200235: KONG-TL VBR System, KONG-C VBR System (2020), 1 descendant of its own
- K252219: Cervical Interbody and VBR Fusion System (2026), 0 descendants of its own
- K232790: KONG®-TL VBR System and KONG® C VBR System (2024), 0 descendants of its own

## Indications for use
The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K172323
Methodology: https://510kreport.com/methodology