# K151977: icotec Pedicle System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Apr 12, 2016 after 270 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: 12 generations back to K990745 (1999). 144 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113058: Tiger Spine System, Corelink, LLC (2012) Summary page 4.
- K072022: Valeo Pedicle Screw Spinal System, Amedica Corp. (2007) Summary page 4.

## Most influential descendants
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K193423: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (2020), 6 descendants of its own

## Indications for use
The icotec Pedicle System is intended to provide immobilization and stabilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (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/K151977
Methodology: https://510kreport.com/methodology