# K212853: Cervical Stand-Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine, LLC
- Decided: Nov 5, 2021 after 59 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: 23 generations back to K841189 (1984). 414 ancestors in all.
18 later devices descend from it; 5 cite it directly.
1 of 433 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200115: Cavetto-SA Cervical Cage System, Neurostructures, Inc. (2020) Summary page 5.
- K173077: Cavetto-SA Cervical Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K200087: F3D Cervical Stand-Alone Interbody Fusion System, Corelink, LLC (2020) Summary page 5.
- K132029: Vault-C Intervertebral Body Fusion Device, Spinal USA (2013) Summary page 5.
- K131880: Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System, Spinefrontier, Inc. (2014) Summary page 5.

## Most influential descendants
- K223105: Tesera-K SC System (2022), 5 descendants of its own
- K223190: Hive™ Standalone Cervical System (2022), 5 descendants of its own
- K240838: Spectrum Spine Cervical Cage System (2024), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own

## Indications for use
The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K212853
Methodology: https://510kreport.com/methodology