510(k) · Cleared
Recalled · Class II · 2012Atlantis Anterior Cervical Plate System, Translational Plate
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 Feb 23, 2007 as substantially equivalent to K030327 (Medtronic Sofamor Danek, 2003) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 2002. 50 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 23, 2007
- Review
- 136 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021461 (2002). 2 ancestors in all. 50 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK021461 Atlantis Vision Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2002 · Recalled
- This deviceK063100 Atlantis Anterior Cervical Plate System, Translational PlateMedtronic Sofamor Danek, Inc. · 2007
- Descendant · cites it directly · 35 of its ownK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- Descendant · 2 generations on · 32 of its ownK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 18 of its ownK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 16 of its ownK141599 Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 3 generations on · 11 of its ownK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K081038Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · cites it directly35descendants
- K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on32descendants
- K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on18descendants
- K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on16descendants
- K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021461 | Atlantis Vision Anterior Cervical Plate System | Medtronic Sofamor Danek | 2002 | 3 |
| 0 (this device) | K063100 | Atlantis Anterior Cervical Plate System, Translational Plate | Medtronic Sofamor Danek, Inc. | 2007 | — |
| +1 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| +2 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +3 | K141599 | Divergence Anterior Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +3 | K140417 | Divergence Mini-Plate Anterior Cervical Fusion System | Medtronic Sofamor Danek, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K030327 | Zephir Anterior Cervical SystemSummary page 1…ertebral Body Fixation Orthosis; Class: 11; Product Code(s): KWQ; and Regulation No.: 888.3060 IV. Legally Marketed Devices: ZEPHIR® Anterior Cervical System (K030327), ATLANTIS® Anterior Cervical Plate System (K021461) V. Description: The ATLANTIS® Anterior Cervical Plate System com… | 2003 |
| * | K021461 | Atlantis Vision Anterior Cervical Plate SystemSummary page 1…Code(s): KWQ; and Regulation No.: 888.3060 IV. Legally Marketed Devices: ZEPHIR® Anterior Cervical System (K030327), ATLANTIS® Anterior Cervical Plate System (K021461) V. Description: The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for… | 2002 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081038 | Atlantis Anterior Cervical Plate System | 2008 | 35 |
| K121049 | Unify Dynamic Anterior Cervical Plate System | 2012 | 10 |
| K152623 | ATLANTIS Anterior Cervical Plate System | 2015 | 9 |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™… | 2019 | 8 |
| K092474 | Pyrenees Cervical Plate System, Semi-Constrained Screws | 2010 | 8 |
| K161641 | LOSPA IS ACP System | 2017 | 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?
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. 2007, 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?
Properly used, this system is intended for anterior interbody screw/plate 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/plate 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/K063100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063100: Atlantis Anterior Cervical Plate System, Translational Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063100
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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