# K173175: Paramount Anterior Cervical Cage System

- Pathway: 510(k) (Special)
- Applicant: Spine Wave, Inc.
- Decided: Nov 1, 2017 after 33 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: 18 generations back to K841189 (1984). 116 ancestors in all.
No later device cites it as a predicate yet.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162760: Spine Wave Anterior Cervical Spine System, Spine Wave, Inc. (2017) Summary page 4.

## Indications for use
The Paramount® Anterior Cervical Cage System is indicated for 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 history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. Paramount® Anterior Cervical Cage System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.

Source page: https://510kreport.com/device/K173175
Methodology: https://510kreport.com/methodology