510(k) · Cleared
ClearedSkyline Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A Johnson & Johnson Company · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 14, 2011 as substantially equivalent to K052552 (Depuy Spine, Inc., 2005) after an 80-day review. Its family tree reaches back 3 generations to 1995. 34 later devices descend from it.
- Decided
- Feb 14, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953730 (1995). 34 later devices descend from it, 14 citing it directly.
- Root · 3 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 2 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 1 generation backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- This deviceK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- Descendant · cites it directly · 7 of its ownK181244 Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · cites it directly · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
- Descendant · cites it directly · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K181244Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018 · cites it directly7descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 2 generations on6descendants
- K153526Pyrenees Cervical Plate SystemK2m · 2016 · cites it directly6descendants
- K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · cites it directly5descendants
- K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −2 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −1 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| 0 (this device) | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| +1 | K181244 | Zavation Cervical Plate System | Zavation Medical Products, LLC | 2018 | — |
| +2 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +1 | K153526 | Pyrenees Cervical Plate System | K2m | 2016 | — |
| +1 | K172104 | Ozark (tm) Cervical Plate System | K2m, Inc. | 2017 | — |
| +2 | K162664 | Pyrenees Cervical Plate System | K2m, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K052552 | Hybrid Anterior Cervical Plate SystemSummary page 1…per 21 CFR §888.3060 D. Predicate Device Name Trade name: SKYLINE® Anterior Cervical Plate System, cleared as the Hybrid Anterior Cervical Plate System (K052552) E. Device Description The SKYLINE® System consists of cervical plates and screws which are… | 2005 |
What descends from it? (34)
See all 3414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181244 | Zavation Cervical Plate System | 2018 | 7 |
| K153526 | Pyrenees Cervical Plate System | 2016 | 6 |
| K172104 | Ozark (tm) Cervical Plate System | 2017 | 5 |
| K130427 | Pioneer Aspect Anterior Cervical Plate System | 2013 | 5 |
| K112724 | Depuy Pulse Anterior Cerical Plate System | 2011 | 2 |
| K222493 | CODA™ Anterior Cervical Plate System | 2022 | 1 |
| K220182 | Aggeris™-C | 2022 | 1 |
| K252776 | ARIES Anterior Cervical Plate Systems | 2026 | 0 |
| K200224 | SEA-LINK Anterior Cervical Plate System | 2020 | 0 |
| 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181244 (Zavation Medical Products, LLC, 2018) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K052552.
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. 2011, 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 SKYLINE® Anterior Cervical Plate System is indicated for stabilization of the cervical spine from 02 to 07 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 pseudloarthorosis as a result of previously failed cervical…
Read the full statement (100 words)
The SKYLINE® Anterior Cervical Plate System is indicated for stabilization of the
cervical spine from 02 to 07 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 pseudloarthorosis 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 as stated in the FDA summary.
https://510kreport.com/device/K103491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103491: Skyline 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/K103491
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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