510(k) · Cleared
ClearedFORTICO Anterior Cervical Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 22, 2019 as substantially equivalent to K132324 (Medos International SARL, 2013) and 4 other predicates after a 130-day review. Its family tree reaches back 17 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 22, 2019
- Review
- 130 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K003155 (2001). 273 ancestors in all, the oldest K761228 (1976). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
- 1 generation backK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- This deviceK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · cites it directly · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · cites it directly · 0 of its ownK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 7 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 6 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 4 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
- 1 generation backK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- This deviceK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −7 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −6 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −4 | K100967 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K132584 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K140417 | Divergence Mini-Plate Anterior Cervical Fusion System | Medtronic Sofamor Danek, Inc. | 2014 | — |
| −1 | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| 0 (this device) | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +1 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +1 | K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 12 | 0 |
| 2003 | 22 | 0 |
| 2004 | 27 | 0 |
| 2005 | 18 | 0 |
| 2006 | 12 | 0 |
| 2007 | 14 | 0 |
| 2008 | 20 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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.
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? (5)
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 |
|---|---|---|---|
| * | K132324 | Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System…Summary page 4…n orthosis Class: II Product Code: KWQ Primary Predicate: Medos International Sárl Uniplate 2 Anterior Cervical Plate System (K132324) Additional Predicate(s): Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846),… | 2013 |
| * | K092146 | Xtend Anterior Cervical Plate SystemSummary page 4…Medos International Sárl Uniplate 2 Anterior Cervical Plate System (K132324) Additional Predicate(s): Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846), Medtronic International ZEVO™ Anterior Cervical Plate System (K18… | 2009 |
| * | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Summary page 4…Uniplate 2 Anterior Cervical Plate System (K132324) Additional Predicate(s): Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846), Medtronic International ZEVO™ Anterior Cervical Plate System (K182885, K… | 2018 |
| * | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Summary page 4…END Anterior Cervical Plate System (K092146, K181846), Medtronic International ZEVO™ Anterior Cervical Plate System (K182885, K141632) Indications for use: The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws… | 2019 |
| * | K141632 | Zevo (TM) Anterior Cervical Plate SystemSummary page 4…K092146, K181846), Medtronic International ZEVO™ Anterior Cervical Plate System (K182885, K141632) Indications for use: The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fix… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 28 of the 273 ancestors have a recall of any class.
- Of its descendants, K232256 (Camber Spine Technologies, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2019, 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 FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications:
degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191584: FORTICO Anterior Cervical 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/K191584
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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