# K230614: Cortium™

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA
- Decided: May 2, 2023 after 57 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: 14 generations back to K003155 (2001). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161032: neon3™  universal OCT spinal stabilization, Ulrich GmbH & Co. KG (2016) Summary page 4.
- K994187: Synthes Cervifix System, Synthes (Usa) (1999) Summary page 4.
- K150650: neon3, Ulrich GmbH & Co. KG (2015) Summary page 4.
- K113346: Neon System, Ulrich GmbH & Co. KG (2012) Summary page 4.

## Indications for use
Cortium is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic 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. Cortium 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, Cortium can also be connected to Momentum via transition rods or connectors. Please refer to the Momentum Instructions for Use for a list of indications for use.

Source page: https://510kreport.com/device/K230614
Methodology: https://510kreport.com/methodology