510(k) · Cleared
ClearedMont Blanc Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineway · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 12, 2015 as substantially equivalent to K112684 (Qualgenix, 2012) after a 105-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it.
- Decided
- May 12, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901587 (1990). 22 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 1 generation backK112684 Mont Blanc Pedicle Screw SystemsQualgenix · 2012
- This deviceK150185 Mont Blanc Spinal SystemSpineway · 2015
- Descendant · cites it directly · 3 of its ownK161387 Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA · 2016
- Descendant · 2 generations on · 0 of its ownK253045 “Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK231658 VEOS Spinal Fixation SystemSpineway · 2023
- Descendant · 2 generations on · 0 of its ownK191726 mont blanc & mont blanc MIS Spinal SystemsSpineway SA · 2019
Most influential descendants
Showing 4 of 4 · See all- K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA · 2016 · cites it directly3descendants
- K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K231658VEOS Spinal Fixation SystemSpineway · 2023 · 2 generations on0descendants
- K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K112684 | Mont Blanc Pedicle Screw Systems | Qualgenix | 2012 | — |
| 0 (this device) | K150185 | Mont Blanc Spinal System | Spineway | 2015 | — |
| +1 | K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | Spineway SA | 2016 | — |
| +2 | K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026 | — |
| +2 | K231658 | VEOS Spinal Fixation System | Spineway | 2023 | — |
| +2 | K191726 | mont blanc & mont blanc MIS Spinal Systems | Spineway SA | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K112684 | Mont Blanc Pedicle Screw SystemsSummary page 4…MontBlancSpinalSystemissubstantiallyequivalenttothepredicate Mont Blanc system(K112684). PerformanceStandards: K150185… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | 2016 | 3 |
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 25 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K161387 (Spineway SA, 2016) has gone furthest, with 3 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. 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 Mont Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fusion 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 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/K150185 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150185: Mont Blanc Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150185
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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