510(k) · Cleared
Recalled · Class II · 2018Zevo (TM) Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 4, 2014 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 4 other predicates after a 169-day review. Its family tree reaches back 7 generations to 1995. 18 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 2014
- Review
- 169 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K953730 (1995). 17 ancestors in all. 18 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 6 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 5 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 4 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 3 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 2 generations backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 9 of its ownK152623 ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK192314 RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly9descendants
- K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc. · 2019 · cites it directly8descendants
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · 2 generations on4descendants
- K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019 · cites it directly3descendants
- K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −6 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −5 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −4 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −2 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| −1 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K152623 | ATLANTIS Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +1 | K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | 2019 | — |
| +2 | K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 5…d bone screws are substantially equivalent to the predicates: Primary Predicate: Anterior Cervical Spine Locking Plate (CSLP) System, (K030866, SE 04/18/2003) [SYNTHES® Spine]… | 2003 |
| * | K130640 | Atlantis Anterior Cervical Plate SystemSummary page 6…Page 3 of 3 Additional predicates: ATLANTIS® Anterior Cervical Plate System (K130640, SE 06/04/2013; K081038, SE 08/15/2008) [Medtronic] ZEPHIR® Anterior Cervical System (K030327, SE 02/26… | 2013 |
| * | K081038 | Atlantis Anterior Cervical Plate SystemSummary page 6…Page 3 of 3 Additional predicates: ATLANTIS® Anterior Cervical Plate System (K130640, SE 06/04/2013; K081038, SE 08/15/2008) [Medtronic] ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003; K994239, SE 06/19… | 2008 |
| * | K030327 | Zephir Anterior Cervical SystemSummary page 6… ATLANTIS® Anterior Cervical Plate System (K130640, SE 06/04/2013; K081038, SE 08/15/2008) [Medtronic] ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003; K994239, SE 06/19/2000) [Medtronic] To the best of Medtronic’s knowledge, none of the predic… | 2003 |
| * | K994239 | Zephir Anterior Cervical Plate SystemSummary page 6…late System (K130640, SE 06/04/2013; K081038, SE 08/15/2008) [Medtronic] ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003; K994239, SE 06/19/2000) [Medtronic] To the best of Medtronic’s knowledge, none of the predicates listed here have been subj… | 2000 |
What descends from it? (18)
See all 187 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152623 | ATLANTIS Anterior Cervical Plate System | 2015 | 9 |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™… | 2019 | 8 |
| K192314 | RESONATE Anterior Cervical Plate System | 2019 | 3 |
| K191584 | FORTICO Anterior Cervical Fixation System | 2019 | 2 |
| K231090 | Zevo Anterior Cervical Plate System | 2023 | 1 |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | 2019 | 1 |
| K223753 | Cervical Plate System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2018 | Class II | Z-1750-2018 | Process control | Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K152623 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 9 descendants of its own.
- 41 other devices also cite its predicate K030866.
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 ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical 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) pseudoathrosis, and/or 6) failed previous fusions.
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/K141632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141632: Zevo (TM) Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141632
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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