# K123568: Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 18, 2012 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
Longest line of descent: 3 generations back to K003780 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082728: Vertex Recontruction System, Vertex  Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2009). Our reading of the summary gave K062728, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VERTEX® Reconstruction System”.
- K023555: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2002) Summary page 4.

## 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: DOD (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. Occjpitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks The occihitocervical 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 (ClI-T3) spine. Multi-axial Screws The use of multi-axial screws is limited to placement in TI-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. Connectors 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®V rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and 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/K123568
Methodology: https://510kreport.com/methodology