# K161649: Virtu C Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Met 1 Technologies, LLC
- Decided: Nov 9, 2016 after 147 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P980048 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 5.

## Most influential descendants
- K222806: Kodiak C Spinal Implant System (2022), 1 descendant of its own
- K230851: Kodiak Lumbar Spacer System (2023), 0 descendants of its own

## Indications for use
When used as an Intervertebral Body Fusion Device: The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocortical bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment. When used as a Vertebral Body Replacement Device: The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

Source page: https://510kreport.com/device/K161649
Methodology: https://510kreport.com/methodology