# K090714: Vertex Reconstruction System, Vertex Select Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Apr 17, 2009 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
Longest line of descent: 3 generations back to K003780 (2001). 8 ancestors in all.
233 later devices descend from it; 10 cite it directly.
0 of 242 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.
- K042789: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.
- K052376: Modification to: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 2.
- K053483: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2006) Summary page 2.
- K014296: CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.

## Most influential descendants
- K111510: CD Horizon Spinal System (2011), 128 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System (2011), 106 descendants of its own
- K113593: Nextgen Altius Oct System (2012), 102 descendants of its own
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own

## Indications for use
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spbndylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. OccipitocervicalComponents: Plate Rod/Plates/Rods/OccipitalScrews/Hooks The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs. 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 (CI -T3) spine. Multi-axial Screws/Connectors The use of multi-axial screws are limited to placement inTI-T3. The 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. In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Source page: https://510kreport.com/device/K090714
Methodology: https://510kreport.com/methodology