# K192268: Europa Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Oct 22, 2019 after 62 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: 8 generations back to K950697 (1995). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180337: EUROPA Pedicle Screw System, MiRus, LLC (2019) Summary page 4.
- K182970: EUROPA™ Pedicle Screw System, MiRus, LLC (2019) Summary page 4.
- K191757: EUROPA Pedicle Screw System, MiRus, LLC (2019) Summary page 4.

## 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/K192268
Methodology: https://510kreport.com/methodology