# K093434: Vertex Reconstruction System and Vertex Select Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 2, 2009 after 28 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K003155 (2001). 77 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042789: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 2.
- K070742: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2007) Summary page 2.
- K071942: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2007) Summary page 2.
- K080805: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2008) Summary page 2.
- K082728: Vertex Recontruction System, Vertex  Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 2.
- K090714: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 2.
- K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.

## Most influential descendants
- K111076: Solanas Avalon Posterior Fixation System (2011), 5 descendants of its own
- K182837: M.U.S.T. Mini Extension (2019), 1 descendant of its own
- K162266: The Cranial Fusion System (2017), 1 descendant of its own
- K203125: Invictus™ OCT Spinal Fixation System (2020), 0 descendants of its own
- K203149: M.U.S.T. MINI Posterior Cervical Screws System (2020), 0 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), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/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 (C1-T3) spine. Multi-axial Screws/Connectors The use of multi-axial screws are limited to placement in T1-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/K093434
Methodology: https://510kreport.com/methodology