# K062505: Nex-Link Spinal Fixation System Offset Connectors, 2121-XX Series

- Pathway: 510(k) (Special)
- Applicant: Abbott Spine, Inc.
- Decided: Sep 26, 2006 after 29 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System, Spinal Concepts, Inc. (2003) Summary page 1.
- K021009: Octafix Occipital Cervical Plating System, Spinal Concepts, Inc. (2002) Summary page 1.

## Most influential descendants
- K113346: Neon System (2012), 1 descendant of its own
- K230614: Cortium™ (2023), 0 descendants of its own
- K142752: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System (2015), 0 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and tie thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylohsthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hlooks and rods are also intended to provide stabilization to promote fusion followng reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine. The use of multiaxial screws is limited to placement in Tl-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K062505
Methodology: https://510kreport.com/methodology