# K253195: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: Jun 2, 2026 after 249 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: 18 generations back to K003155 (2001). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180851: VERTEX™ Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 6.
- K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System, Medos International SARL (2019) Summary page 6.
- K233078: Posterior Cervical Spine System, Double Medical Technology, Inc. (2023) Summary page 6.

## Indications for use
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems 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 and the thoracic spine (Occiput-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and 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 TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems 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 advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K253195
Methodology: https://510kreport.com/methodology