# K242516: EUROPA™ Posterior Cervical Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Nov 19, 2024 after 88 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: 17 generations back to K853033 (1985). 206 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182508: Saxxony™ Posterior Cervical Thoracic System, Nexxt Spine, LLC (2018)
- K180337: EUROPA Pedicle Screw System, MiRus, LLC (2019)

## Most influential descendants
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (2026), 0 descendants of its own

## Indications for use
The EUROPA™ Posterior Cervical Fusion 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 cervical spine (C1 to C7) and the upper 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 * Degenerative disease, including intractable radiculopathy and/or myelopathy * Neck and/or arm pain of discogenic origin as confirmed by radiographic studies * Degenerative disease of the facets with instability The EUROPA™ Posterior Cervical Fusion 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 EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.

Source page: https://510kreport.com/device/K242516
Methodology: https://510kreport.com/methodology