# K162760: Spine Wave Anterior Cervical Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Feb 16, 2017 after 139 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: 17 generations back to K841189 (1984). 115 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150765: LDR Spine ROI-C Cervical Cage System, Ldr Spine USA (2015) Summary page 4.
- K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer, Choice Spine, Llp (2009) Summary page 4.
- K152620: Spine Wave Gen II Expandable Interbody System, Spine Wave, Inc. (2016) Summary page 4.
- K153222: Leva Spacer System, Spine Wave, Inc. (2016) Summary page 4.
- K081228: Capsure PS (R) Spine System, Spine Wave, Inc. (2008) Summary page 4.

## Most influential descendants
- K173175: Paramount Anterior Cervical Cage System (2017), 0 descendants of its own

## Indications for use
The Spine Wave Anterior Cervical Spine 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. The Spine Wave Anterior Cervical Spine 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/K162760
Methodology: https://510kreport.com/methodology