510(k) · Cleared
ClearedDymaxeon Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B2b Spine Pty, Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 5, 2012 as substantially equivalent to K110321 (Corelink, LLC, 2011) and 5 other predicates after a 140-day review. Its family tree reaches back 12 generations to 1999. 1 of the 174 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Nov 5, 2012
- Review
- 140 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K990745 (1999). 168 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly. 1 of the 174 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations between
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 1 generation backK113058 Tiger Spine SystemCorelink, LLC · 2012
- This deviceK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK150184 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK170989 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK192930 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK180754 C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd. · 2018
Show all 12 generations
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 10 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 9 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 8 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 7 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 6 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 5 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 4 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 1 generation backK113058 Tiger Spine SystemCorelink, LLC · 2012
- This deviceK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015 · cites it directly4descendants
- K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017 · cites it directly2descendants
- K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020 · 2 generations on1descendant
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 3 generations on0descendants
- K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −11 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −10 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −9 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −8 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −7 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −6 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −5 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −4 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −3 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −2 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| −1 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| 0 (this device) | K121786 | Dymaxeon Spine System | B2b Spine Pty, Ltd. | 2012 | — |
| +1 | K150184 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2015 | 1 |
| +1 | K170989 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2017 | — |
| +2 | K192930 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2020 | — |
| +3 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | 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 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 12 | 0 |
| 2001 | 11 | 0 |
| 2002 | 5 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K110321 | Tiger Spine SystemSummary page 2…tion presented in the 51 0(k) supports the substantial equivalence of the Dymaxeon Spine System to the following predicate devices: Corelink, LLC Tiger T Spine System (K110321, KI 13058), DePuy Moss Miami (K103490, etc), Synthes Universal Reduction Screw (K120571, etc), and Scient'x ISOBAR (K9901 18, K0… | 2011 |
| * | K113058 | Tiger Spine System | 2012 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 2…the substantial equivalence of the Dymaxeon Spine System to the following predicate devices: Corelink, LLC Tiger T Spine System (K110321, KI 13058), DePuy Moss Miami (K103490, etc), Synthes Universal Reduction Screw (K120571, etc), and Scient'x ISOBAR (K9901 18, K013444). Substantial Equivalence: Th… | 2011 |
| * | K120571 | Synthes Uss ConnectorSummary page 2…System to the following predicate devices: Corelink, LLC Tiger T Spine System (K110321, KI 13058), DePuy Moss Miami (K103490, etc), Synthes Universal Reduction Screw (K120571, etc), and Scient'x ISOBAR (K9901 18, K013444). Substantial Equivalence: The components of the Dymaxeon Spine System are subst… | 2012 |
| * | K990118 | Isobar Spinal SystemSummary page 2…evices: Corelink, LLC Tiger T Spine System (K110321, KI 13058), DePuy Moss Miami (K103490, etc), Synthes Universal Reduction Screw (K120571, etc), and Scient'x ISOBAR (K9901 18, K013444). Substantial Equivalence: The components of the Dymaxeon Spine System are substantially equivalent to the identifie… | 1999 |
| * | K013444 | Isobar Spinal SystemSummary page 2…relink, LLC Tiger T Spine System (K110321, KI 13058), DePuy Moss Miami (K103490, etc), Synthes Universal Reduction Screw (K120571, etc), and Scient'x ISOBAR (K9901 18, K013444). Substantial Equivalence: The components of the Dymaxeon Spine System are substantially equivalent to the identified predica… | 2001 |
What descends from it? (5)
2 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)
No FDA recall names this device.
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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 15 of the 168 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150184 (Back 2 Basics Direct, LLC, 2015) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K110321.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 (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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121786: 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/K121786
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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