510(k) · Cleared
ClearedKing Cobra Anterior Cervical Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eminent Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 14, 2011 as substantially equivalent to K945700 (Synthes (Usa), 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jan 14, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945700 (1995). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945700 Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1995
- This deviceK103068 King Cobra Anterior Cervical PlateEminent Spine · 2011
- Descendant · cites it directly · 1 of its ownK201979 Cervical Plate SystemEminent Spine, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK231145 Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1995 | — |
| 0 (this device) | K103068 | King Cobra Anterior Cervical Plate | Eminent Spine | 2011 | — |
| +1 | K201979 | Cervical Plate System | Eminent Spine, LLC | 2020 | — |
| +2 | K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty), Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 1…manufactured from titanium alloy (Ti-6A-4V) as described by ASTM F136. Predicate Devices: Cervical Spine Locking Plate (K945700/K030866) Page 14… | 1995 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 1…manufactured from titanium alloy (Ti-6A-4V) as described by ASTM F136. Predicate Devices: Cervical Spine Locking Plate (K945700/K030866) Page 14… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201979 | Cervical Plate System | 2020 | 1 |
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?
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 King CobraTM Cervical Plate System is intended for anterior screw fixation of the cervical spine (02-07) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (ice., fractures or dislocations), spinal stenosis, deformity (i.e., kylphosis, lordosis or scoliosis), tumor, pseudlarthrosis or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103068: King Cobra Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103068
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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