510(k) · Cleared
ClearedAdmiral ACP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 26, 2020 as substantially equivalent to K173521 (SeaSpine Orthopedics Corporation, 2018) and 1 other predicate after a 30-day review. Its family tree reaches back 9 generations to 1992. 14 later devices descend from it.
- Decided
- Aug 26, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K922087 (1992). 34 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 5 generations between
- 3 generations backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- 2 generations backK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- 1 generation backK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- This deviceK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · cites it directly · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 6 of its ownK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 2 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK252611 aprevo® cervical plating systemCarlsmed, Inc. · 2025
- Descendant · 3 generations on · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
Show all 9 generations
- Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 8 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 7 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 6 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 5 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 4 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 3 generations backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- 2 generations backK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- 1 generation backK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- This deviceK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · cites it directly7descendants
- K212139Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly6descendants
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 2 generations on5descendants
- K252611aprevo® cervical plating systemCarlsmed, Inc. · 2025 · 2 generations on3descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −8 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −7 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −6 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −5 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −4 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −3 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| −2 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| −1 | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | 2018 | — |
| 0 (this device) | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
| +1 | K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021 | — |
| +2 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec… | Alphatec Spine, Inc. | 2024 | — |
| +2 | K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025 | — |
| +3 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSummary page 4…ade Name Manufacturer Primary Predicate Device SeaSpine Cabo ACP (Anterior SeaSpine Orthopedics K173521 KWQ Cervical Plate) System Corporation Additional Predicate Dev… | 2018 |
| * | K112206 | Cardiff Anterior Cervical Plate SystemSummary page 4…SeaSpine, Inc. Cardiff Anterior Cervical Plate (formerly known as K112206 KWQ Integra LifeSciences Sy… | 2012 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K211903 (SeaSpine Orthopedics Corporation, 2021) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K173521.
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
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 Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:
•Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
•Spondylolisthesis,
•Trauma (i.e., fracture or dislocation),
•Spinal Stenosis,
•Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
•Tumor,
•Pseudoarthrosis,
•and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202064: Admiral ACP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202064
Report an extraction error
Are you the manufacturer?
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