510(k) · Cleared
Recalled · Class II · 2021Insignia™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 21, 2020 as substantially equivalent to K131374 (Neurostructures, LLC, 2013) and 2 other predicates after a 35-day review. Its family tree reaches back 6 generations to 1995. 7 later devices descend from it. It has been recalled 29 times.
- Decided
- May 21, 2020
- Review
- 35 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 29
- Predicates
- 3
Its longest line of descent runs back 6 generations to K953730 (1995). 27 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 1 generation backK133518 Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- This deviceK200995 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK213443 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
- Descendant · 4 generations on · 0 of its ownK251575 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF…Alphatec Spine · 2025
- Descendant · 2 generations on · 0 of its ownK251965 Proximity Anterior Cervical Plate System; Segmental Plating System…Alphatec Spine, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
2021high 5 (2025) · low 0 (2022)2026
Most influential descendants
Showing 5 of 7 · See all- K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2021 · cites it directly6descendants
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 2 generations on5descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · 3 generations on3descendants
- K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine · 2025 · 4 generations on0descendants
- K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −5 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −4 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −3 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −1 | K133518 | Maxan Anterior Cervical Plate System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| 0 (this device) | K200995 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2020 | — |
| +1 | K213443 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | 2021 | — |
| +2 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec… | Alphatec Spine, Inc. | 2024 | — |
| +3 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
| +4 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone… | Alphatec Spine | 2025 | — |
| +2 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K131374 | Tempus (TM) Cervical Plate SystemSummary page 4…e Manufacturer Primary Predicate Device Tempus Anterior Cervical Plate NeuroStructure, K131374 KWQ System LLC Additional Predicate Devi… | 2013 |
| * | K102820 | Appliance, Fixation, Spinal Intervertebral BodySummary page 4…LLC Additional Predicate Device Trestle Luxe Anterior Cervical Alphatec Spine, K102820 KWQ Plating System Inc.… | 2010 |
| * | K133518 | Maxan Anterior Cervical Plate SystemSummary page 4…Q Plating System Inc. MaxAn Anterior Cervical Plate K133518 KWQ Zimmer Biomet System… | 2014 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213443 | Insignia™ Anterior Cervical Plate System | 2021 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2021 | Class II | Z-1821-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1812-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1806-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1800-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1818-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1802-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1826-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1824-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1803-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1808-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1820-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1827-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1817-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1811-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1804-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1823-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1825-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1807-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1799-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1810-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1814-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1816-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1813-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1805-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1809-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1819-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1801-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1822-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Apr 26, 2021 | Class II | Z-1815-2021 | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K213443 (Alphatec Spine, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K131374.
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. 2020, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2007high 32 (2008) · low 7 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
2007high 124 (2014) · low 55 (2020)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
2007high 35 (2009) · low 0 (2014)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
2007high 796 (2013) · low 248 (2025)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 Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
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/K200995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200995: Insignia™ 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/K200995
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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