# K220658: COSY Cervicothoracic Occipital Rod-Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Nov 18, 2022 after 256 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953076 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160697: Gibralt® Spine System and Gibralt® Occipital Spine System, Exactech, Inc. (2016). Our OCR of the scanned summary read K160197, FDA’s number for Haemonetics Cell Saver Elite Autotransfusion System (Haemonetics Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Gibralt Spine System”.

## Indications for use
The COSY Cervicothoracic Occipital Rod-Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instabilities or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion. In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.

Source page: https://510kreport.com/device/K220658
Methodology: https://510kreport.com/methodology