# K173126: Arisstos™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ingenium Spine
- Decided: Dec 5, 2017 after 67 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: 17 generations back to K040583 (2004). 138 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051704: Mykres Spinal System, Showa Ika Kohgyo Co., Ltd. (2006) Summary page 4.
- K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 4.
- K163301: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.

## Most influential descendants
- K241258: Ingenix Spinal System (2024), 0 descendants of its own

## Indications for use
The Arisstos™ Spinal 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). The Arisstos™ Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K173126
Methodology: https://510kreport.com/methodology