# K192208: CORNICE Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Legend Spine Technologies
- Decided: Oct 9, 2019 after 56 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: 20 generations back to K841189 (1984). 214 ancestors in all.
No later device cites it as a predicate yet.
1 of 215 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181140: Axis Chena Cervical PEEK Spacer System, Axis Orthopaedics (2018) Summary page 5.
- K111983: Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 5.
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 5.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 5.

## Indications for use
The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K192208
Methodology: https://510kreport.com/methodology