510(k) · Cleared
ClearedDymaxeon 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 May 12, 2020 as substantially equivalent to K170989 (Back 2 Basics Direct, LLC, 2017) and 3 other predicates after a 208-day review. Its family tree reaches back 15 generations to 1999. 1 of the 192 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 12, 2020
- Review
- 208 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K990745 (1999). 190 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 192 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations between
- 3 generations backK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
- 2 generations backK150184 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015 · Recalled
- 1 generation backK170989 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017
- This deviceK192930 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020
- Descendant · cites it directly · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 14 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 13 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 12 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 11 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 10 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 9 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 8 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 7 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 6 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 5 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 4 generations backK113058 Tiger Spine SystemCorelink, LLC · 2012
- 3 generations backK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
- 2 generations backK150184 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015 · Recalled
- 1 generation backK170989 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017
- This deviceK192930 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −14 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −13 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −12 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −11 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −10 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −9 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −8 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −7 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −6 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −5 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| −4 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −3 | K121786 | Dymaxeon Spine System | B2b Spine Pty, Ltd. | 2012 | — |
| −2 | K150184 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2015 | 1 |
| −1 | K170989 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2017 | — |
| 0 (this device) | K192930 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2020 | — |
| +1 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
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 | 12 | 0 |
| 1999 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 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 |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K170989 | Dymaxeon Spine SystemSummary page 4…are manufactured from titanium alloy (Ti-6Al-4V ELI, per ASTM F136). Primary Predicate: Dymaxeon Spine System (Back 2 Basics Direct LLC – K170989) Additional Predicates: Dymaxeon Spine System (Back 2 Basics Direct LLC – K150184), Optima™ Spinal Sys… | 2017 |
| * | K150184 | Dymaxeon Spine SystemSummary page 4…STM F136). Primary Predicate: Dymaxeon Spine System (Back 2 Basics Direct LLC – K170989) Additional Predicates: Dymaxeon Spine System (Back 2 Basics Direct LLC – K150184), Optima™ Spinal System (U&I Corporation – K051971), GII Osta-Pek® Plate (coLigne… | 2015 |
| * | K051971 | Optima Spinal SystemSummary page 4…ect LLC – K170989) Additional Predicates: Dymaxeon Spine System (Back 2 Basics Direct LLC – K150184), Optima™ Spinal System (U&I Corporation – K051971), GII Osta-Pek® Plate (coLigne AG – K051089)… | 2005 |
| * | K051089 | Gii Spinal Fixation SystemSummary page 4…ck 2 Basics Direct LLC – K150184), Optima™ Spinal System (U&I Corporation – K051971), GII Osta-Pek® Plate (coLigne AG – K051089) K192930 - Page 2 of 2 Performance Data:… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243106 | CarboClear® Hybrid Pedicle Screw System | 2024 | 0 |
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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 20 of the 190 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243106 (CarboFix Orthopedics, Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma…
Read the full statement (99 words)
The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192930: 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/K192930
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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