# K233078: Posterior Cervical Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Nov 22, 2023 after 58 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: 17 generations back to K003155 (2001). 169 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210449: Infinity™ OCT System, PASS OCT® Spinal System, Medtronic (2021) Summary page 4.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.

## Most influential descendants
- K253195: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (2026), 0 descendants of its own

## Indications for use
The Posterior Cervical Spine 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 to C7), and the thoracic spine from T1-T2: (1)Traumatic spinal fractures and/or traumatic dislocations. (2)Instability or deformity. (3)Failed previous fusions (e.g. pseudarthrosis). (4)Tumors involving the cervical spine. (5)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.

Source page: https://510kreport.com/device/K233078
Methodology: https://510kreport.com/methodology