# K081297: Vertex Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jun 11, 2008 after 35 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
239 later devices descend from it; 2 cite it directly.
0 of 240 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 its predicate without a number.
- (no number) VERTEX® Reconstruction System: named in the summary without a submission number

## Most influential descendants
- K083071: Vertex Reconstruction System (2008), 223 descendants of its own
- K082728: Vertex Recontruction System, Vertex  Select Reconstruction System (2009), 146 descendants of its own
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System (2009), 138 descendants of its own
- K111510: CD Horizon Spinal System (2011), 128 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own

## Recalls of this device
- Mar 26, 2020 · Class II · Z-1941-2020: Nonconforming product; length of the product measured shorter than the labeled length.

## Indications for use
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-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 and/or tumors. Occipitocervical Components: PlateRod/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 (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/K081297
Methodology: https://510kreport.com/methodology