510(k) · Cleared
Recalled · Class II · 2018Dymaxeon Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Back 2 Basics Direct, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 15, 2015 as substantially equivalent to K121786 (B2b Spine Pty, Ltd., 2012) and 4 other predicates after a 139-day review. Its family tree reaches back 13 generations to 1999. 1 of the 190 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 15, 2015
- Review
- 139 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 13 generations to K990745 (1999). 185 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 3 citing it directly. 1 of the 190 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations between
- 3 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 2 generations backK113058 Tiger Spine SystemCorelink, LLC · 2012
- 1 generation backK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
- This deviceK150184 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015
- Descendant · cites it directly · 2 of its ownK170989 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017
- Descendant · cites it directly · 1 of its ownK192930 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK180754 C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd. · 2018
Show all 13 generations
- Root · 13 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 12 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 11 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 10 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 9 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 8 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 7 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 6 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 5 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 4 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 3 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 2 generations backK113058 Tiger Spine SystemCorelink, LLC · 2012
- 1 generation backK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
- This deviceK150184 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 4 of 4 · See all- K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017 · cites it directly2descendants
- K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020 · cites it directly1descendant
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on0descendants
- K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −12 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −11 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −10 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −9 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −8 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −7 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −6 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −5 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −4 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −3 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| −2 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −1 | K121786 | Dymaxeon Spine System | B2b Spine Pty, Ltd. | 2012 | — |
| 0 (this device) | K150184 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2015 | — |
| +1 | K170989 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2017 | — |
| +1 | K192930 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2020 | — |
| +2 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | Signature Orthopaedics Pty, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 8 | 0 |
| 1998 | 11 | 0 |
| 1999 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 1 |
| 2011 | 7 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121786 | Dymaxeon Spine SystemSummary page 5…Page 2 of 2 Ø5.5 mm rod component option, a cannulated screw option to the currently marketed Ø6.0 mm rods and solid screws cleared in K121786, a transverse connector to increase torsional rigidity, and hook options (laminar, pedicular, and offset) to provide the surgeon… | 2012 |
| * | K113058 | Tiger Spine SystemSummary page 5…onents are substantially equivalent to the p r i m a r y predicate Dymaxeon Spine System (K121786). Additional predicate devices include the Corelink Tiger Spine System (K113058), the Blackstone SFS Parallel Rod Connectors (K080407), the Synthes Anterior CSLP System (K000536), and the Stryker Xia Spinal Sy… | 2012 |
| * | K080407 | Blackstone SFS Parallel Rod ConnectorsSummary page 5…y predicate Dymaxeon Spine System (K121786). Additional predicate devices include the Corelink Tiger Spine System (K113058), the Blackstone SFS Parallel Rod Connectors (K080407), the Synthes Anterior CSLP System (K000536), and the Stryker Xia Spinal System (K071373). Technological Characteristics: The Ø5… | 2008 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 5…. Additional predicate devices include the Corelink Tiger Spine System (K113058), the Blackstone SFS Parallel Rod Connectors (K080407), the Synthes Anterior CSLP System (K000536), and the Stryker Xia Spinal System (K071373). Technological Characteristics: The Ø5.5mm rod, cannulated screw, and transverse c… | 2000 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 5…relink Tiger Spine System (K113058), the Blackstone SFS Parallel Rod Connectors (K080407), the Synthes Anterior CSLP System (K000536), and the Stryker Xia Spinal System (K071373). Technological Characteristics: The Ø5.5mm rod, cannulated screw, and transverse connector components are substantially equival… | 2007 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2018 | Class II | Z-2881-2018 | Labeling mix-ups | Packages labeled as containing 110mm rods may contain 100mm rods. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 19 of the 185 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170989 (Back 2 Basics Direct, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K121786.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150184: Dymaxeon Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150184
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026