# K182151: MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Oct 11, 2018 after 64 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K160677: Microruptor 6, Meridian AG (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K101458: Lina Xcise Model  Mor-1515, Lina Medical Aps (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K151507: AUSSIE™ Anterior Cervical Interbody Fusion Cage System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K220513: NITRO Interbody Fusion Cage System Family (2023), 0 descendants of its own

## Indications for use
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. If the MONET Anterior Cervical Interbody Fusion Cage System is used without the Supplementary Fixation Plate assembly, note that supplementary fixation is still required.

Source page: https://510kreport.com/device/K182151
Methodology: https://510kreport.com/methodology