# K162575: Z-LINKPC System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Mar 3, 2017 after 169 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: 15 generations back to K003155 (2001). 103 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 4.
- K122378: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 4.

## Most influential descendants
- K250866: Sovereign Posterior Cervical System (2025), 1 descendant of its own
- K254260: The VEGA Cervical Screw System (2026), 0 descendants of its own
- K231811: Zavation Connector System (2023), 0 descendants of its own

## Indications for use
The Z-LINKPpc System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic 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. These implants are 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. In order to achieve additional levels of fixation, the Z-LINKPrc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.

Source page: https://510kreport.com/device/K162575
Methodology: https://510kreport.com/methodology