# K152338: VERTEX (r) Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 28, 2015 after 70 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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 K953076 (1997). 4 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System (2016), 17 descendants of its own
- K163375: INFINITY™ OCT System (2017), 16 descendants of its own
- K171444: YUKON OCT Spinal System (2017), 13 descendants of its own
- K180851: VERTEX™ Reconstruction System (2018), 8 descendants of its own
- K182182: YUKON OCT Spinal System (2018), 5 descendants of its own

## Indications for use
The VERTEX® Reconstruction System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. 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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. 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/K152338
Methodology: https://510kreport.com/methodology