510(k) · Cleared
Recalled · Class II · 2012Atlantis 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 Aug 15, 2008 as substantially equivalent to K970806 (Sofamor Danek USA,Inc., 1997) and 3 other predicates after a 126-day review. Its family tree reaches back 5 generations to 1995. 35 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 15, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 5 generations to K953730 (1995). 13 ancestors in all. 35 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 3 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 2 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 1 generation backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- This deviceK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 32 of its ownK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 18 of its ownK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 16 of its ownK141599 Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 11 of its ownK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK152623 ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly32descendants
- K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly18descendants
- K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on16descendants
- K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014 · 2 generations on11descendants
- K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −3 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −2 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −1 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| 0 (this device) | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | — |
| +1 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +2 | K141599 | Divergence Anterior Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K140417 | Divergence Mini-Plate Anterior Cervical Fusion System | Medtronic Sofamor Danek, Inc. | 2014 | — |
| +2 | K152623 | ATLANTIS Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K970806 | Acpii Anterior Cervical Plate SystemSummary page 1…Bone Fixation Appliance; Class: 1I; Product Code(s): KWQ; and Regulation No.: 888.3060 IV. Legally Marketed Devices: ATLANTIS® Anterior Cervical Plate System (K970806) V. Description: The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for… | 1997 |
| * | K021461 | Atlantis Vision Anterior Cervical Plate SystemSummary page 2…11~c 3 u-)S zJ)-2 -2) ATLANTIS" Anterior Cervical Plate System plates previously cleared in K970806, K021461 and K063100 and the C-Tek® MaxAnTM Anterior Cervical Plate System cleared in K080646. DEPARTMENT OF HE… | 2002 |
| * | K063100 | Atlantis Anterior Cervical Plate System, Translational PlateSummary page 2…1~c 3 u-)S zJ)-2 -2) ATLANTIS" Anterior Cervical Plate System plates previously cleared in K970806, K021461 and K063100 and the C-Tek® MaxAnTM Anterior Cervical Plate System cleared in K080646. DEPARTMENT OF HEALTH & HUMAN… | 2007 |
| * | K080646 | C-Tek Maxan Anterior Cervical Plate System Cleared while this submission was under review Summary page 2…-2) ATLANTIS" Anterior Cervical Plate System plates previously cleared in K970806, K021461 and K063100 and the C-Tek® MaxAnTM Anterior Cervical Plate System cleared in K080646. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2008 |
What descends from it? (35)
See all 355 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)
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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K130640 (Medtronic Sofamor Danek USA, Inc., 2013) has gone furthest, with 32 descendants of its own.
- 1 other device also cites its predicate K970806.
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. 2008, 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 from C2 to TI. 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…
Read the full statement (134 words)
Properly used, this system is intended for anterior interbody screw/plate fixation from C2 to TI. 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/K081038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081038: Atlantis 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/K081038
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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