# K162682: MATISSE Anterior Cervical Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Jun 1, 2017 after 248 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MATISSE Anterior Cervical Interbody Fusion Cage System: named in the summary without a submission number

## Most influential descendants
- K172788: MONET™ Anterior Cervical Interbody Fusion Cage System (2018), 1 descendant of its own
- K172212: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ (2018), 1 descendant of its own
- K220513: NITRO Interbody Fusion Cage System Family (2023), 0 descendants of its own
- K192044: 4CIS Marlin PEEK ACIF Cage (2019), 0 descendants of its own

## Indications for use
MATISSE 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. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE 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/K162682
Methodology: https://510kreport.com/methodology