# K241657: MSFX Mikron Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti.
- Decided: Sep 30, 2024 after 112 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). 78 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171497: Mikron Spinal Fixation System, Mikron Makina Sanayi Ticaret Co., Ltd. (2017) Summary page 5.
- K212220: ArtFX Spinal Fixation System, Artfx Medical, LLC (2023) Summary page 5.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 5.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 5.

## Most influential descendants
- K243946: EffortMed Spinal Fixation System (2025), 1 descendant 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
MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft 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 (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/K241657
Methodology: https://510kreport.com/methodology