# K262091: FRAXION Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ortler Global Tibbi Gerecler Anonim Sirketi
- Decided: Sep 17, 2026 after 87 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: 1 generation back to K212220 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212220: ArtFX Spinal Fixation System, Artfx Medical, LLC (2023) Summary page 5.

## Indications for use
FRAXION SPINAL FIXATION SYSTEM is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the FRAXION SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; * Spondylolisthesis; * Trauma, including fracture or dislocation; * Spinal stenosis; * Curvatures, including scoliosis, kyphosis, and/or lordosis; * Tumor; * Pseudoarthrosis; and * Failed previous fusion.

Source page: https://510kreport.com/device/K262091
Methodology: https://510kreport.com/methodology