# K150184: Dymaxeon Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Back 2 Basics Direct, LLC
- Decided: Jun 15, 2015 after 139 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K990745 (1999). 185 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 190 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121786: Dymaxeon Spine System, B2b Spine Pty, Ltd. (2012) Summary page 5.
- K113058: Tiger Spine System, Corelink, LLC (2012) Summary page 5.
- K080407: Blackstone SFS Parallel Rod Connectors, Blackstone Medical, Inc. (2008) Summary page 5.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 5.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 5.

## Most influential descendants
- K170989: Dymaxeon Spine System (2017), 2 descendants of its own
- K192930: Dymaxeon Spine System (2020), 1 descendant of its own
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own
- K180754: C-Zero Pedicle Screw System, Freedom Pedicle Screw System (2018), 0 descendants of its own

## Recalls of this device
- Jun 29, 2018 · Class II · Z-2881-2018: Packages labeled as containing 110mm rods may contain 100mm rods.

## 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/K150184
Methodology: https://510kreport.com/methodology