# K253045: “Socko” Vimax Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Socko Medical Co., Ltd.
- Decided: Jun 17, 2026 after 268 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: 15 generations back to K853033 (1985). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems, Spineway SA (2016) Summary page 5.

## Indications for use
The “Socko” Vimax Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The “Socko” Vimax Spinal Fixation System can be used in a percutaneous approach. The “Socko” Vimax Spinal Fixation System is intended for noncervical pedicle fixation from T1 to S1 for the following indications: degenerative disc disease (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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K253045
Methodology: https://510kreport.com/methodology