# K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Sep 11, 2003 after 76 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
No predicates in its family tree.
75 later devices descend from it; 10 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic Sofamor Danek VERTEX Reconstruction System: named in the summary without a submission number

## Most influential descendants
- K050979: S4 Spinal System (2005), 67 descendants of its own
- K060152: Modification to S4 Spinal System (2006), 32 descendants of its own
- K103414: Venus Cervical Spinal Fixation System (2011), 16 descendants of its own
- K120879: Lexus Cervical Fixation System (2012), 15 descendants of its own
- K110197: Exactech Gibralt Spinal System (2011), 15 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, (C 1-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 (C 1-T3). spine. The use of multiaxial screws is limited to placement in T1 -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/K031985
Methodology: https://510kreport.com/methodology