# K183091: Elaris Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinewelding AG
- Decided: Aug 2, 2019 after 269 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: 14 generations back to K040583 (2004). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170347: CD HORIZON™ Fenestrated Screw Set, Medtronic Sofamor Danek USA (2017) Summary page 4.

## Indications for use
The Elaris Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed above.

Source page: https://510kreport.com/device/K183091
Methodology: https://510kreport.com/methodology