510(k) · Cleared
ClearedThreshold Pedicular Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 18, 2014 as substantially equivalent to K140010 (Spineology, Inc., 2014) after a 20-day review. Its family tree reaches back 16 generations to 2004. 8 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 20 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K040583 (2004). 114 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140010 Fortress Pedicle Screw SystemSpineology, Inc. · 2014
- This deviceK143403 Threshold Pedicular Fixation SystemSpineology, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK153323 Palisade Pedicular Fixation SystemSpineology, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation…Spineology, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK161694 Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK170266 Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK171438 Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140010 Fortress Pedicle Screw SystemSpineology, Inc. · 2014
- This deviceK143403 Threshold Pedicular Fixation SystemSpineology, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153323Palisade Pedicular Fixation SystemSpineology, Inc. · 2016 · cites it directly7descendants
- K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc. · 2016 · cites it directly6descendants
- K161694Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016 · cites it directly3descendants
- K170266Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017 · 2 generations on2descendants
- K171438Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −2 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K140010 | Fortress Pedicle Screw System | Spineology, Inc. | 2014 | — |
| 0 (this device) | K143403 | Threshold Pedicular Fixation System | Spineology, Inc. | 2014 | — |
| +1 | K153323 | Palisade Pedicular Fixation System | Spineology, Inc. | 2016 | — |
| +1 | K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | Spineology, Inc. | 2016 | — |
| +1 | K161694 | Threshold™ Pedicular Fixation System | Spineology, Inc. | 2016 | — |
| +2 | K170266 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | — |
| +3 | K171438 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 14 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 17 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 5 | 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.
Planning a device in NKB? 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? (1)
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 |
|---|---|---|---|
| * | K140010 | Fortress Pedicle Screw SystemSummary page 4…ixation (21 CFR §888.3070) Regulatory Class: Class III Product Code: NKB, MNI, MNH III. PREDICATE DEVICE Primary Predicate - Spineology Fortress™ Pedicle Screw System (K140010) IV. DEVICE DESCRIPTION The Spineology Threshold ™ Pedicular Fixation System is an addition to Spineology’s Fortress pedicle… | 2014 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153323 | Palisade Pedicular Fixation System | 2016 | 7 |
| K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | 2016 | 6 |
| K161694 | Threshold™ Pedicular Fixation System | 2016 | 3 |
| K170255 | Threshold™ V2 Pedicular Fixation System | 2017 | 1 |
| K170251 | Threshold™ Pedicular Fixation System | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 14 of the 114 ancestors have a recall of any class.
- Of its descendants, K153323 (Spineology, Inc., 2016) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K140010.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to
fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis; trauma,
(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis;
and/or failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143403: Threshold Pedicular Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143403
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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