# K222041: CYGNUS-C Standalone ACIF System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Feb 9, 2023 after 213 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
Longest line of descent: 15 generations back to K003155 (2001). 145 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131449: Coalition Spacer, Globus Medical, Inc. (2013) Summary page 5.
- K153517: AnyPlus® Cervical PEEK Cage System, GS Medical Co., Ltd. (2016) Summary page 5.
- K181115: CxHA PEEK Cervical IBF System, Innovasis, Inc. (2018) Summary page 5.

## Most influential descendants
- K231808: QUASAR Standalone ACIF System (2023), 0 descendants of its own

## Indications for use
The GS Medical CYGNUS-C Standalone ACIF 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. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. 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/K222041
Methodology: https://510kreport.com/methodology