# K170989: Dymaxeon Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Back 2 Basics Direct, LLC
- Decided: May 22, 2017 after 49 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: 14 generations back to K990745 (1999). 186 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 189 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150184: Dymaxeon Spine System, Back 2 Basics Direct, LLC (2015) Summary page 4.
- K121786: Dymaxeon Spine System, B2b Spine Pty, Ltd. (2012) Summary page 4.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 4.

## Most influential descendants
- K192930: Dymaxeon Spine System (2020), 1 descendant of its own
- 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 in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K170989
Methodology: https://510kreport.com/methodology