510(k) · Cleared
Recalled · Class II · 2012Atlantis Vision Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 22, 2002 after a 76-day review. The FDA summary names its predicate without a number. 157 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 22, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 3
- Predicates
- 0
157 later devices descend from it, 14 citing it directly.
- This deviceK021461 Atlantis Vision Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2002
- Descendant · cites it directly · 97 of its ownK131025 Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 50 of its ownK063100 Atlantis Anterior Cervical Plate System, Translational PlateMedtronic Sofamor Danek, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
Showing 5 of 157 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 157 · See all- K131025Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013 · cites it directly97descendants
- K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · 2 generations on94descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 3 generations on83descendants
- K063100Atlantis Anterior Cervical Plate System, Translational PlateMedtronic Sofamor Danek, Inc. · 2007 · cites it directly50descendants
- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021461 | Atlantis Vision Anterior Cervical Plate System | Medtronic Sofamor Danek | 2002 | — |
| +1 | K131025 | Archon Anterior Cervical Plate System | Nuvasive, Inc. | 2013 | — |
| +2 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +3 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +1 | K063100 | Atlantis Anterior Cervical Plate System, Translational Plate | Medtronic Sofamor Danek, Inc. | 2007 | 3 |
| +4 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 19 | 0 |
| 2024 | 23 | 0 |
| 2025 | 29 | 0 |
| 2026 | 21 | 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? (1)
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 |
|---|---|---|---|
| * | — | ATLANTIS Anterior Cervical Plate System Named without a submission number |
What descends from it? (157)
See all 15714 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131025 | Archon Anterior Cervical Plate System | 2013 | 97 |
| K063100 | Atlantis Anterior Cervical Plate System, Translational Plate | 2007 | 50 |
| K081038 | Atlantis Anterior Cervical Plate System | 2008 | 35 |
| K130640 | Atlantis Anterior Cervical Plate System | 2013 | 32 |
| K152623 | ATLANTIS Anterior Cervical Plate System | 2015 | 9 |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™… | 2019 | 8 |
| K173867 | Axis Anterior Cervical Plate System | 2018 | 1 |
| K071990 | Valeo Cervical Plate System | 2007 | 1 |
| K252776 | ARIES Anterior Cervical Plate Systems | 2026 | 0 |
| K203154 | KASILOF Cervical Plate System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2012 | Class II | Z-0036-2013 | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
| Aug 30, 2012 | Class II | Z-0038-2013 | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
| Aug 30, 2012 | Class II | Z-0037-2013 | Nonconforming Material/Component | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131025 (Nuvasive, Inc., 2013) has gone furthest, with 97 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.
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?
Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. 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…
Read the full statement (134 words)
Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. 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) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021461: Atlantis Vision 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/K021461
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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