# K203129: NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Jan 12, 2021 after 85 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: 16 generations back to K003155 (2001). 196 ancestors in all.
No later device cites it as a predicate yet.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132029: Vault-C Intervertebral Body Fusion Device, Spinal USA (2013) Summary page 5.
- K173077: Cavetto-SA Cervical Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 5.
- K152793: Unison-C Anterior Cervical Fixation System, Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (2016) Summary page 5.

## Indications for use
The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Source page: https://510kreport.com/device/K203129
Methodology: https://510kreport.com/methodology