# K212220: ArtFX Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Artfx Medical, LLC
- Decided: Apr 20, 2023 after 643 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mikron Spinal Fixation System: named in the summary without a submission number
- (no number) CD HORIZON Spinal System: named in the summary without a submission number
- (no number) USS Small Stature: named in the summary without a submission number
- (no number) VIA Spinal System: named in the summary without a submission number

## Most influential descendants
- K241657: MSFX Mikron Spinal Fixation System (2024), 3 descendants of its own
- K243946: EffortMed Spinal Fixation System (2025), 1 descendant of its own
- K262091: FRAXION Spinal Fixation System (2026), 0 descendants of its own
- K254247: Osteomni Spinal Fixation System (2026), 0 descendants of its own
- K250092: HC Biologics Osteopoint Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
ARTFX SPINAL FIX/\ TTON SYSTEM is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusian 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 discogenie origin with degeneration of the disc confirmed by history and radiographic studies); -Spondylolisthesis; - Trauma (i.e. f racture or dislocation); -Spinal stenosis; -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor: -Pseudoarthrosis; and Failed previous fusion

Source page: https://510kreport.com/device/K212220
Methodology: https://510kreport.com/methodology