# K192930: Dymaxeon Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Back 2 Basics Direct, LLC
- Decided: May 12, 2020 after 208 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: 15 generations back to K990745 (1999). 190 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 192 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170989: Dymaxeon Spine System, Back 2 Basics Direct, LLC (2017) Summary page 4.
- K150184: Dymaxeon Spine System, Back 2 Basics Direct, LLC (2015) Summary page 4.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 4.
- K051089: Gii Spinal Fixation System, Co-Ligne AG (2005) Summary page 4.

## Most influential descendants
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.

Source page: https://510kreport.com/device/K192930
Methodology: https://510kreport.com/methodology