# K172212: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Jan 9, 2018 after 169 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 5.
- K162682: MATISSE Anterior Cervical Interbody Fusion Cage System, Ctl Medical Corporation (2017) Summary page 5.

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

## Indications for use
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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, Ti-PEEK™ 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, Ti-PEEK™ 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/K172212
Methodology: https://510kreport.com/methodology