# K042789: Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 21, 2004 after 76 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: 1 generation back to K003780 (2001). 1 ancestor in all.
325 later devices descend from it; 10 cite it directly.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 2.

## Most influential descendants
- K053483: Modification to Vertex Reconstruction System (2006), 262 descendants of its own
- K090714: Vertex Reconstruction System, Vertex Select Reconstruction System (2009), 233 descendants of its own
- K083071: Vertex Reconstruction System (2008), 223 descendants of its own
- K052180: Modification to Vertex Reconstruction System (2005), 187 descendants of its own
- K052734: Modification to: Vertex Reconstruction System (2005), 175 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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. 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 (C I-T3) spine. Screws/Connectors The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine. Titanium ATLAS™ Cable used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K042789
Methodology: https://510kreport.com/methodology