# K171497: Mikron Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Mikron Makina Sanayi Ticaret Co., Ltd.
- Decided: Oct 12, 2017 after 143 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: 5 generations back to K951116 (1995). 37 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130073: Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal Rods, Mikron Makina Sanayi VE Ticaret Ltd. Sti. (2013) Summary page 5.
- K123476: Mega 5.5 Spine System, Lsk Biopartners, Inc. (2013) Summary page 5.

## 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
- 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
Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion. Mikron Spinal Fixation System is also 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: Degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K171497
Methodology: https://510kreport.com/methodology