510(k) · Cleared
ClearedCardiff Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 25, 2012 as substantially equivalent to K083338 (Seaspine, Inc., 2009) and 1 other predicate after a 177-day review. Its family tree reaches back 2 generations to 1993. 15 later devices descend from it.
- Decided
- Jan 25, 2012
- Review
- 177 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926453 (1993). 7 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 1 generation backK083338 Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2009
- This deviceK112206 Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
- Descendant · 2 generations on · 6 of its ownK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 3 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK252611 aprevo® cervical plating systemCarlsmed, Inc. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · cites it directly14descendants
- K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · 2 generations on7descendants
- K212139Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on6descendants
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 3 generations on5descendants
- K252611aprevo® cervical plating systemCarlsmed, Inc. · 2025 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −1 | K083338 | Cardiff Anterior Cervical Plate System | Seaspine, Inc. | 2009 | — |
| 0 (this device) | K112206 | Cardiff Anterior Cervical Plate System | Seaspine, Inc. | 2012 | — |
| +1 | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021 | — |
| +2 | K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021 | — |
| +3 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec… | Alphatec Spine, Inc. | 2024 | — |
| +3 | K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K083338 | Cardiff Anterior Cervical Plate SystemSummary page 1…Class 11)(Orthopedic Review Committee) Locally Marketed Predicate Device Previously cleared Cardiff ' Anterior Cervical Plate System 51 0(k) (K083338) Previously cleared Sonomam Anterior Cervical Plate System 510(k) (K032368) Device Description The Cardiff ' Anterior Cervical P… | 2009 |
| * | K032368 | Sonoma Anterior Cervical Plate SystemSummary page 1…Marketed Predicate Device Previously cleared Cardiff ' Anterior Cervical Plate System 51 0(k) (K083338) Previously cleared Sonomam Anterior Cervical Plate System 510(k) (K032368) Device Description The Cardiff ' Anterior Cervical Plate (ACP) System is intended for anterior interbody screw fixation of the… | 2003 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202064 | Admiral ACP System | 2020 | 14 |
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 19 years and passes through 2 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K202064 (SeaSpine Orthopedics Corporation, 2020) has gone furthest, with 14 descendants of its own.
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. 2012, 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?
This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:
* degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
* trauma (including fracture or dislocation),
* spinal stenosis,
* cervical myelopathy,
* deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordlosis),
* tumor,
* pseudloarthrosis, and/or
* failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112206: Cardiff 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/K112206
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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