# K200549: Lucero Medical Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Lucero Medical, LLC
- Decided: Dec 16, 2020 after 288 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). 237 ancestors in all.
No later device cites it as a predicate yet.
1 of 238 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.
- K181483: Tranquil Interbody System, Nexus Spine, LLC (2018) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.

## Indications for use
The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat 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 multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K200549
Methodology: https://510kreport.com/methodology