# K163474: CAVUX CervicalCage-L SA System

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Mar 10, 2017 after 88 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 12 generations back to K841189 (1984). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150053: STALIF C; STALIF C-Ti, Centinel Spine, Inc. (2015) Summary page 5.
- K142079: Stalif Cti, Stalif C, Centinel Spine, Inc. (2014) Summary page 5.
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 5.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 5.
- K152515: TOMCAT Cervical Spinal System, Choicespine, LP (2015) Summary page 5.
- K150765: LDR Spine ROI-C Cervical Cage System, Ldr Spine USA (2015) Summary page 5.
- K121103: LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa MC Implant S, Ldr Spine USA, Inc. (2012) Summary page 5.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 5.

## Indications for use
CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

Source page: https://510kreport.com/device/K163474
Methodology: https://510kreport.com/methodology