# K043578: The 4CIS Spinal System and 4CIS Low Back System

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Mar 7, 2005 after 69 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 3 generations back to K000319 (2000). 7 ancestors in all.
125 later devices descend from it; 2 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001668: Global Spinal Fixation System, D.K.M. Co., Ltd. (2000) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K103085: Venus Basic Spinal Fixation System (2011), 123 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own

## Indications for use
The 4CIS® Spinal System & 4CIS® Low Back System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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 attainment of a solid fusion. In addition, the 4CIS® Spinal System/4CIS® Low Back 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: 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/K043578
Methodology: https://510kreport.com/methodology