# K121786: Dymaxeon Spine System

- Pathway: 510(k) (Traditional)
- Applicant: B2b Spine Pty, Ltd.
- Decided: Nov 5, 2012 after 140 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). 168 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 174 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110321: Tiger Spine System, Corelink, LLC (2011) Summary page 2.
- K113058: Tiger Spine System, Corelink, LLC (2012)
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 2.
- K120571: Synthes Uss Connector, Synthes Spine (2012) Summary page 2.
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 2.
- K013444: Isobar Spinal System, Scien'Tx USA, Inc. (2001) Summary page 2.

## Most influential descendants
- K150184: Dymaxeon Spine System (2015), 4 descendants of its own
- 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

## 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 (TI - Si/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/K121786
Methodology: https://510kreport.com/methodology