# K243188: Cylox® ST

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Feb 11, 2025 after 134 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: 20 generations back to K841189 (1984). 262 ancestors in all.
No later device cites it as a predicate yet.
1 of 263 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201646: Shoreline ACS (Anterior Cervical System), SeaSpine Orthopedics Corporation (2020) Summary page 5.

## Indications for use
The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach. When used as a standalone system, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX® ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw. When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

Source page: https://510kreport.com/device/K243188
Methodology: https://510kreport.com/methodology