510(k) · Cleared
ClearedMont Blanc Pedicle Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualgenix · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 1, 2012 as substantially equivalent to K962628 (Depuy, Inc., 1997) and 3 other predicates after a 229-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- May 1, 2012
- Review
- 229 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K901587 (1990). 21 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 2 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 1 generation backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- This deviceK112684 Mont Blanc Pedicle Screw SystemsQualgenix · 2012
- Descendant · cites it directly · 4 of its ownK150185 Mont Blanc Spinal SystemSpineway · 2015
- Descendant · 2 generations on · 3 of its ownK161387 Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA · 2016
- Descendant · 3 generations on · 0 of its ownK253045 “Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK231658 VEOS Spinal Fixation SystemSpineway · 2023
- Descendant · 3 generations on · 0 of its ownK191726 mont blanc & mont blanc MIS Spinal SystemsSpineway SA · 2019
Most influential descendants
Showing 5 of 5 · See all- K150185Mont Blanc Spinal SystemSpineway · 2015 · cites it directly4descendants
- K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA · 2016 · 2 generations on3descendants
- K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd. · 2026 · 3 generations on0descendants
- K231658VEOS Spinal Fixation SystemSpineway · 2023 · 3 generations on0descendants
- K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −2 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −1 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| 0 (this device) | K112684 | Mont Blanc Pedicle Screw Systems | Qualgenix | 2012 | — |
| +1 | K150185 | Mont Blanc Spinal System | Spineway | 2015 | — |
| +2 | K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | Spineway SA | 2016 | — |
| +3 | K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026 | — |
| +3 | K231658 | VEOS Spinal Fixation System | Spineway | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K962628 | Moss Miami Spinal SystemSummary page 2…s and has the same indications for use, design, function, and materials used. Cleared devices include the DePuy MOSS Miami (K962628), Biomet Synergy VLS Open (K973836), Synthes Pangea (K052123) and Zimmer Silhouette… | 1997 |
| * | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Summary page 2…use, design, function, and materials used. Cleared devices include the DePuy MOSS Miami (K962628), Biomet Synergy VLS Open (K973836), Synthes Pangea (K052123) and Zimmer Silhouette (K(993067). Performance Testing: Testing performed ind… | 1998 |
| * | K052123 | Synthes Pangea SystemSummary page 2…materials used. Cleared devices include the DePuy MOSS Miami (K962628), Biomet Synergy VLS Open (K973836), Synthes Pangea (K052123) and Zimmer Silhouette (K(993067). Performance Testing: Testing performed indicates the Mont Blanc Pedi… | 2005 |
| * | K993067 | Silhouette Spinal Fixation SystemSummary page 2…nclude the DePuy MOSS Miami (K962628), Biomet Synergy VLS Open (K973836), Synthes Pangea (K052123) and Zimmer Silhouette (K(993067). Performance Testing: Testing performed indicates the Mont Blanc Pedicle Screw System is substantially… | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150185 | Mont Blanc Spinal System | 2015 | 4 |
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 22 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K150185 (Spineway, 2015) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K962628.
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 Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the Ti to Si vertebrae 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; pseudarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112684: Mont Blanc Pedicle Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112684
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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