# K042498: Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Oct 7, 2004 after 23 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- 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.
188 later devices descend from it; 3 cite it directly.
0 of 190 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
- K052180: Modification to Vertex Reconstruction System (2005), 187 descendants of its own
- 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

## Recalls of this device
- Jun 28, 2011 · Not classified · Z-2877-2011: Screws are longer then size etched on the screw.

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the VERTEXTM 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 1-T3) spine. 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 ATLASTNI Cable used with the VERTEXTM Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K042498
Methodology: https://510kreport.com/methodology