# K193465: CorticaLINK Spinal Fusion Platform

- Pathway: 510(k) (Special)
- Applicant: Spine Smith Holdings, LLC
- Decided: Jan 10, 2020 after 25 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: 10 generations back to K853033 (1985). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160722: CorticaLINK Spinal Fusion Platform, Facetlink Dba Linkspine (2016) Summary page 5.

## Indications for use
The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients: * degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * trauma (i.e., fracture or dislocation) * spinal stenosis * curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * tumor * pseudoarthrosis * and failed previous fusion

Source page: https://510kreport.com/device/K193465
Methodology: https://510kreport.com/methodology