# K090060: Nexlink Oct System, Model 7000 Series

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Spine, Inc.
- Decided: Jun 2, 2009 after 144 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011969 (2001). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021009: Octafix Occipital Cervical Plating System, Spinal Concepts, Inc. (2002) Summary page 1.

## Most influential descendants
- K121877: Gibralt  Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates (2013), 4 descendants of its own
- K133374: Streamline Oct Occipito-Cervico-Thoracic System (2014), 3 descendants of its own
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), 2 descendants of its own
- K161498: Streamline OCT Occipito-Cervico-Thoracic System (2016), 1 descendant of its own
- K113346: Neon System (2012), 1 descendant of its own

## Indications for use
The Nex-Link OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors. The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

Source page: https://510kreport.com/device/K090060
Methodology: https://510kreport.com/methodology