# K241258: Ingenix Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ingenium Spine
- Decided: Jun 4, 2024 after 29 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: 18 generations back to K040583 (2004). 139 ancestors in all.
No later device cites it as a predicate yet.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173126: Arisstos™ Spinal System, Ingenium Spine (2017) Summary page 5.

## Indications for use
The Ingenix™ 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra with autogenous bone graft, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K241258
Methodology: https://510kreport.com/methodology