# K023555: Modification to Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Nov 22, 2002 after 30 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
No predicates in its family tree.
381 later devices descend from it; 4 cite it directly.
1 of 382 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K042524: Modification to Vertex Reconstruction System (2004), 373 descendants of its own
- K042402: Modification to Vertex Reconstruction System (2004), 259 descendants of its own
- K052376: Modification to: Vertex Reconstruction System (2005), 254 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

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine, (C 1-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 andor 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. Sere ws/Corzizectors The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1- T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine. Titanium ATLASTMCable used with the VERTEXTMReconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K023555
Methodology: https://510kreport.com/methodology