# K052180: Modification to Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 23, 2005 after 13 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: 2 generations back to K003780 (2001). 3 ancestors in all.
187 later devices descend from it; 4 cite it directly.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042498: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.
- K042789: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K052734: Modification to: Vertex Reconstruction System (2005), 175 descendants of its own
- K062879: Traverse Oct Spinal Fixation System (2006), 151 descendants of its own
- K070742: Modification to Vertex Reconstruction System (2007), 150 descendants of its own
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System (2009), 138 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 cervical spine and the thoracic spine, (CI-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 (Cl-T3) spine. Screws/Connrectors The use of screws (3.5mm and 4.0mam cancellous, and 4.0amm 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 ATLASTNI Cable used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K052180
Methodology: https://510kreport.com/methodology