# K160722: CorticaLINK Spinal Fusion Platform

- Pathway: 510(k) (Traditional)
- Applicant: Facetlink Dba Linkspine
- Decided: Jul 7, 2016 after 113 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: 9 generations back to K853033 (1985). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 6.
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 6.
- K111940: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2012) Summary page 6.

## Most influential descendants
- K193465: CorticaLINK Spinal Fusion Platform (2020), 0 descendants of its own
- K173484: CorticaLINK Spinal Fusion Platform (2017), 0 descendants of its own

## 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: x degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); x spondylolisthesis; x trauma (i.e., fracture or dislocation); x spinal stenosis; x curvatures (i.e., scoliosis, kyphosis, and/or lordosis); x tumor; x pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K160722
Methodology: https://510kreport.com/methodology