# K102458: 4CIS Solar Spine System and 4CIS Apollon Spine System

- Pathway: 510(k) (Special)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Jun 13, 2011 after 290 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.
4 later devices descend 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.

## Most influential descendants
- K202498: 4CIS SARA Spine System, 4CIS VERTU Spine System (2021), 3 descendants of its own
- K242827: A8 INTEGR8™ Porous Pedicle Screws (2025), 1 descendant of its own
- K262067: iFuse Granite Onyx™ Implant System (2026), 0 descendants of its own
- K232607: 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM (2024), 0 descendants of its own

## Indications for use
The 4C15® SOLAR Spine System and 4C15® APOLLON Spine System are 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 4C15® SOLAR Spine System and 4C15® APOLLON Spine System are 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/K102458
Methodology: https://510kreport.com/methodology