510(k) · Cleared
Recalled · Class II · 2016Hybrid Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 13, 2005 as substantially equivalent to K013877 (Codman & Shurtleff, Inc., 2001) after a 27-day review. Its family tree reaches back 2 generations to 1995. 39 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 13, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953730 (1995). 39 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 1 generation backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- This deviceK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005
- Descendant · cites it directly · 34 of its ownK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- Descendant · 2 generations on · 7 of its ownK181244 Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018
- Descendant · 3 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · 2 generations on · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
- Descendant · 2 generations on · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K103491Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011 · cites it directly34descendants
- K181244Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018 · 2 generations on7descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 3 generations on6descendants
- K153526Pyrenees Cervical Plate SystemK2m · 2016 · 2 generations on6descendants
- K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −1 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| 0 (this device) | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | — |
| +1 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| +2 | K181244 | Zavation Cervical Plate System | Zavation Medical Products, LLC | 2018 | — |
| +3 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +2 | K153526 | Pyrenees Cervical Plate System | K2m | 2016 | — |
| +2 | K172104 | Ozark (tm) Cervical Plate System | K2m, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K013877 | Codman Slim-Loc SystemSummary page 4…Orthosis §888.3060 PROPRIETARY NAME: Hybrid Anterior Cervical Plate System PREDICATE DEVICE: SLIM-LOCTM Anterior Cervical Plate System, K01 3877 DEVICE DESCRIPTION: The Hybrid Anterior Cervical Plate System consists of an assortment of plate and sc… | 2001 |
What descends from it? (39)
See all 394 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103491 | Skyline Anterior Cervical Plate System | 2011 | 34 |
| K130427 | Pioneer Aspect Anterior Cervical Plate System | 2013 | 5 |
| K132324 | Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System… | 2013 | 3 |
| K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2016 | Class II | Z-0627-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Class II | Z-0628-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Class II | Z-0629-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Class II | Z-0626-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Class II | Z-0624-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Class II | Z-0625-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Class II | Z-0630-2017 | Under Investigation by firm | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
The 5 latest of 7 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 10 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K103491 (A Johnson & Johnson Company, 2011) has gone furthest, with 34 descendants of its own.
- 8 other devices also cite its predicate K013877.
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?
The Hybrid Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine…
Read the full statement (100 words)
The Hybrid Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy
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/K052552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052552: Hybrid 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/K052552
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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