# K191778: Omnia Medical VBR

- Pathway: 510(k) (Special)
- Applicant: Omnia Medical, LLC
- Decided: Aug 28, 2019 after 57 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- 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: 14 generations back to K003155 (2001). 44 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180550: NuVasive Monolith Cervical Corpectomy System, Nu Vasive, Incorporated (2018) Summary page 4.
- K172323: Omnia Medical VBR, Omnia Medical, LLC (2017) Summary page 4.

## Most influential descendants
- 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
- K230329: F3D Interbody System (2023), 0 descendants of its own

## Indications for use
The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K191778
Methodology: https://510kreport.com/methodology