# K022015: Modification to Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 18, 2002 after 28 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.
22 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have 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
- K062934: Sierra (2006), 21 descendants of its own
- K080526: Sierra System (2008), 9 descendants of its own
- K133698: Synapse System (2014), 6 descendants of its own
- K141897: Synapse System, Synthes OC Fusion System (2014), 5 descendants of its own
- K072729: Sierra (2008), 5 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 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 cervicalhpper thoracic (C1-T3) spine. ScrewdConnectors 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 ATLAST™ Cable used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Source page: https://510kreport.com/device/K022015
Methodology: https://510kreport.com/methodology