# K053483: Modification to Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jan 5, 2006 after 21 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 K003780 (2001). 2 ancestors in all.
262 later devices descend from it; 3 cite it directly.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042789: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K090714: Vertex Reconstruction System, Vertex Select Reconstruction System (2009), 233 descendants of its own
- K070742: Modification to Vertex Reconstruction System (2007), 150 descendants of its own
- K111510: CD Horizon Spinal System (2011), 128 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System (2011), 106 descendants of its own

## Indications for use
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction 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. Occipitocervical Plate/Rod/Occipital Screws/Hooks The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous along with 4.0mm and 4.5mm cortical), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Multi-axial Screws/Connectors The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K053483
Methodology: https://510kreport.com/methodology