510(k) · Cleared
ClearedDivergence Mini-Plate Anterior Cervical Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 9, 2014 as substantially equivalent to K030327 (Medtronic Sofamor Danek, 2003) and 9 other predicates after a 141-day review. Its family tree reaches back 15 generations to 2001. 11 later devices descend from it.
- Decided
- Jul 9, 2014
- Review
- 141 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 15 generations to K003155 (2001). 109 ancestors in all, the oldest K792352 (1979). 11 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK142450 DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 3 generations on · 1 of its ownK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · Recalled
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc. · 2019 · cites it directly8descendants
- K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly6descendants
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · 2 generations on4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
- K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −5 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −2 | K100967 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −1 | K132584 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | K142450 | DIVERGENCE Anterior Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +2 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +3 | K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 16 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (10)
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 |
|---|---|---|---|
| * | K030327 | Zephir Anterior Cervical SystemSummary page 3…Equivalence The subject mini plate and bone screws are substantially equivalent to the predicates: * ZEPHIR® Anterior Cervical System (K030327, SE 02/26/03) "ATLANTIS® Anterior Cervical Plate System (K1 30640, SE 06/04/13) K14 04 17… | 2003 |
| * | K130640 | Atlantis Anterior Cervical Plate SystemSummary page 3…stantially equivalent to the predicates: * ZEPHIR® Anterior Cervical System (K030327, SE 02/26/03) "ATLANTIS® Anterior Cervical Plate System (K1 30640, SE 06/04/13) K14 04 17 Page 4 o… | 2013 |
| * | K130177 | Anatomic Peek Cervical Fusion SystemSummary page 4…Page 4 of 4 The subject interbody cage is substantially equivalent to the predicates: * ANATOMIC PEEK Cervical Fusion System (K1 30177, SE 09/23/13; KI 12444, SE 11/15/1 1) * CORNERSTONE®) PSR Cervical Fusion System (KI 11264, SE 10/1… | 2013 |
| * | K112444 | Anatomic Peek Cervical Fusion System | 2011 |
| * | K111264 | Cornerstone (R) PSR Cervical Fusion System | 2011 |
| * | K113252 | Peek Prevail Cervical Interbody DeviceSummary page 4…SE 11/15/1 1) * CORNERSTONE®) PSR Cervical Fusion System (KI 11264, SE 10/12/11) " PEEK PREVAIL® Cervical Interbody Device (KI 113252, SE 1/17/12; K094042, SE 06/30/10) " AFFINITY® Anterior Cervical Cage System (P000028, Approval Date… | 2012 |
| * | K094042 | Peek Prevail Cervical Interbody DeviceSummary page 4…11/15/1 1) * CORNERSTONE®) PSR Cervical Fusion System (KI 11264, SE 10/12/11) " PEEK PREVAIL® Cervical Interbody Device (KI 113252, SE 1/17/12; K094042, SE 06/30/10) " AFFINITY® Anterior Cervical Cage System (P000028, Approval Date 07/13/02,… | 2010 |
| * | P000028 | Affinity (TM) Cage SystemSummary page 4…" PEEK PREVAIL® Cervical Interbody Device (KI 113252, SE 1/17/12; K094042, SE 06/30/10) " AFFINITY® Anterior Cervical Cage System (P000028, Approval Date 07/13/02, down-classified to Class 11 special controls, Date of Final Order 06/12/07)… | 2002 |
| * | K132584 | Perimeter C Spinal SystemSummary page 4…(P000028, Approval Date 07/13/02, down-classified to Class 11 special controls, Date of Final Order 06/12/07) * PERIMETER® C Spinal System (K132584, SE 12/04/13; K100967, SE 08/05/11) X. Brief Discussion of the Non-Clinical Tests Submitted… | 2013 |
| * | K100967 | Perimeter C Spinal SystemSummary page 4…e 07/13/02, down-classified to Class 11 special controls, Date of Final Order 06/12/07) * PERIMETER® C Spinal System (K132584, SE 12/04/13; K100967, SE 08/05/11) X. Brief Discussion of the Non-Clinical Tests Submitted The subject DIVERGENC… | 2011 |
What descends from it? (11)
See all 112 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 13 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 10 of the 109 ancestors have a recall of any class.
- Of its descendants, K182885 (Medtronic Sofamor Danek USA, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 12 other devices also cite its predicate K030327.
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. 2014, 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 DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by…
Read the full statement (247 words)
The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.
The DIVERGENCE™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
When used together, the DIVERGENCE™ components can be used only to treat cervical disc disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140417: Divergence Mini-Plate Anterior Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140417
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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