# K172788: MONET™ Anterior Cervical Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Jun 25, 2018 after 283 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 13 generations back to K841189 (1984). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121569: Matisse Anterior Cervical Interbody Fusion Cage System, Accel Spine (2012) Summary page 4.
- K162682: MATISSE Anterior Cervical Interbody Fusion Cage System, Ctl Medical Corporation (2017) Summary page 4.

## 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 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. MONET™ Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. MONET™ Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K172788
Methodology: https://510kreport.com/methodology