# K162402: 4CIS® Marlin ACIF Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Feb 16, 2017 after 174 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: 14 generations back to K003155 (2001). 100 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 4.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 4.
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 4.
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 4.
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S, Spineart (2009) Summary page 4.

## Most influential descendants
- K192044: 4CIS Marlin PEEK ACIF Cage (2019), 0 descendants of its own

## Indications for use
4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

Source page: https://510kreport.com/device/K162402
Methodology: https://510kreport.com/methodology