# K232607: 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Copany India Private Limited
- Decided: Feb 27, 2024 after 183 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: 5 generations back to K000319 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202498: 4CIS SARA Spine System, 4CIS VERTU Spine System, Solco Biomedical Company India Private Limited (2021) Summary page 5.

## Indications for use
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-Sl 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. The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW 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 ). aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to used for Minimal Invasive Surgery (MIS).

Source page: https://510kreport.com/device/K232607
Methodology: https://510kreport.com/methodology