# K130073: Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal Rods

- Pathway: 510(k) (Traditional)
- Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti.
- Decided: Dec 16, 2013 after 339 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 4 generations back to K000319 (2000). 8 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063708: 4S Spinal System, Taeyeon Medical Co., Ltd. (2007) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K171497: Mikron Spinal Fixation System (2017), 4 descendants of its own
- K241657: MSFX Mikron Spinal Fixation System (2024), 3 descendants of its own
- 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
Tbe MSFX 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 the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (TI to 52): severe spoudylolisthesis (grades 3 and 4) of the L5-S I vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K130073
Methodology: https://510kreport.com/methodology