510(k) · Cleared
ClearedFortiBridge Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanovis Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 26, 2016 as substantially equivalent to K143706 (Nanovis Spine, LLC, 2015) and 1 other predicate after a 77-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Oct 26, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K953730 (1995). 19 ancestors in all, the oldest K945700 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 7 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 6 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 5 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 4 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 3 generations backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK143706 FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC · 2015
- This deviceK162250 FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −7 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −6 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −5 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −3 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| −2 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K143706 | FortiBridge Anterior Cervical Plate System | Nanovis Spine, LLC | 2015 | — |
| 0 (this device) | K162250 | FortiBridge Anterior Cervical Plate System | Nanovis Spine, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2014 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K143706 | FortiBridge Anterior Cervical Plate SystemSummary page 5…ridge™ implants are manufactured from titanium alloy as described by ASTM F136. Primary Predicate: FortiBridge™ System (Nanovis Spine, LLC – K143706) Additional Predicate: MaxAn® Anterior Cervical Plate System (Biomet Spine, LLC – K133518) Performance Data: Performance… | 2015 |
| * | K133518 | Maxan Anterior Cervical Plate SystemSummary page 5…ASTM F136. Primary Predicate: FortiBridge™ System (Nanovis Spine, LLC – K143706) Additional Predicate: MaxAn® Anterior Cervical Plate System (Biomet Spine, LLC – K133518) Performance Data: Performance data was not provided in this submission Technological The FortiBridge™ System pos… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 19 ancestors have a recall of any class.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162250: FortiBridge Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162250
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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