# K003780: Vertex Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Sep 28, 2001 after 295 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.
420 later devices descend from it; 21 cite it directly.
1 of 421 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
- K042789: Vertex Reconstruction System (2004), 325 descendants of its own
- K053483: Modification to Vertex Reconstruction System (2006), 262 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

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine Cl T3 the VERTE3P 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 Multi axial Screws Lateral Connectors The use of multi axial screws 3 5mm and 4 0mm cancellous and 4 0mm cortical is limited to placement in Tl T3 in treating thoracic conditions only The multi axial screws are not intended to be placed in the cervical spine Titanium ATLAS Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine

Source page: https://510kreport.com/device/K003780
Methodology: https://510kreport.com/methodology