510(k) · Cleared
Recalled · Class II · 2015Maxan Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine (Aka Ebi, LLC) · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 5, 2014 as substantially equivalent to K080646 (Biomet Spine, 2008) after a 355-day review. Its family tree reaches back 5 generations to 1995. 25 later devices descend from it. It has been recalled once.
- Decided
- Nov 5, 2014
- Review
- 355 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953730 (1995). 9 ancestors in all. 25 later devices descend from it, 12 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 deviceK133518 Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 2014
- Descendant · cites it directly · 7 of its ownK200995 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 6 of its ownK213443 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2021
- Descendant · 3 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024
- Descendant · 4 generations on · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
- Descendant · cites it directly · 3 of its ownK162638 CETRA Anterior Cervical Plate SystemOrthofix, Inc. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020 · cites it directly7descendants
- K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2021 · 2 generations on6descendants
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 3 generations on5descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · 4 generations on3descendants
- K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. · 2016 · cites it directly3descendants
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) | K133518 | Maxan Anterior Cervical Plate System | Biomet Spine (Aka Ebi, LLC) | 2014 | — |
| +1 | K200995 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2020 | 29 |
| +2 | K213443 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2021 | — |
| +3 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec… | Alphatec Spine, Inc. | 2024 | — |
| +4 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
| +1 | K162638 | CETRA Anterior Cervical Plate System | Orthofix, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K080646 | C-Tek Maxan Anterior Cervical Plate SystemSummary page 4…pliance, Fixation, Spinal Intervertebral Body (KWQ) (Product Code): Device Panel - Regulation Orthopedic - 21 CFR 888.3060 No.: Primary Predicate: K080646 Device Description: The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws… | 2008 |
What descends from it? (25)
See all 2512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200995 | Insignia™ Anterior Cervical Plate System | 2020 | 7 |
| K162638 | CETRA Anterior Cervical Plate System | 2016 | 3 |
| K150666 | uNion Cervical Plate System | 2015 | 3 |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | 2020 | 1 |
| K191786 | Cyclops™ Anterior Cervical Plate System | 2019 | 1 |
| K240515 | uNion® MAX Cervical Plate System | 2024 | 0 |
| K221053 | Magnes-C Anterior Cervical Plate System | 2023 | 0 |
| K200927 | Transept Cervical Plate System | 2020 | 0 |
| K173306 | EZ Plate | 2018 | 0 |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2015 | Class II | Z-0203-2016 | Labeling mix-ups | The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K200995 (Alphatec Spine, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 10 other devices also cite its predicate K080646.
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 MaxAn" Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.
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/K133518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133518: Maxan 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/K133518
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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