# K121615: 4CIS Vane Spine System

- Pathway: 510(k) (Special)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Aug 15, 2012 after 75 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 K000319 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.
- K101818: 4CIS Vane Spine System, Solco Biomedical Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K181995: Chiral Surgical Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
The 4C15 VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

Source page: https://510kreport.com/device/K121615
Methodology: https://510kreport.com/methodology