# K180337: EUROPA Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Mar 14, 2019 after 400 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K950697 (1995). 31 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 4.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 4.
- K071495: Expedium 4.5MM Spine System, Depuy Spine, A Johnson & Johnson Company (2007) Summary page 4.
- K082942: Modfication to: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 4.

## Most influential descendants
- K242516: EUROPA™ Posterior Cervical Fusion System (2024), 2 descendants of its own
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own
- K191757: EUROPA Pedicle Screw System (2019), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants 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™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K180337
Methodology: https://510kreport.com/methodology