# K081145: Modification to 4CIS Vane Spine System

- Pathway: 510(k) (Special)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Nov 5, 2008 after 197 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: 3 generations back to K000319 (2000). 5 ancestors in all.
127 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)
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K010668: Bayer Diagnostics Advia Centaur Rubella Igm Assay, Bayer Corp. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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® VANE Spine System is 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® VANE Spine 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/K081145
Methodology: https://510kreport.com/methodology