# K060634: Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Spine, Inc.
- Decided: Mar 31, 2006 after 22 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031985 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052566: Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120.  Nex-Link Spinal Fixation SY, Abbott Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Dec 1, 2005 · Not classified · Z-0605-2011: The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
- Dec 1, 2005 · Not classified · Z-0602-2011: The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
- Dec 1, 2005 · Not classified · Z-0603-2011: The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
- Dec 1, 2005 · Not classified · Z-0604-2011: The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.

## Indications for use
When intended to promote fusion of the cervical spine and the 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), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following 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/K060634
Methodology: https://510kreport.com/methodology