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 Sep 1, 2021 as substantially equivalent to K202064 (SeaSpine Orthopedics Corporation, 2020) and 1 other predicate after a 55-day review. Its family tree reaches back 10 generations to 1992. 6 later devices descend from it.
- Decided
- Sep 1, 2021
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K922087 (1992). 35 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations between
- 3 generations backK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- 2 generations backK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- 1 generation backK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 3 of its ownK252611 aprevo® cervical plating systemCarlsmed, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK260570 corra™ cervical plating systemCarlsmed, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK262149 corra® cervical plating systemCarlsmed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 9 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 8 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 7 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 6 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 5 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 4 generations backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- 3 generations backK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- 2 generations backK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- 1 generation backK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K252611aprevo® cervical plating systemCarlsmed, Inc. · 2025 · cites it directly3descendants
- K260570corra™ cervical plating systemCarlsmed, Inc. · 2026 · 2 generations on1descendant
- K262149corra® cervical plating systemCarlsmed, Inc. · 2026 · 3 generations on0descendants
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · cites it directly0descendants
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −9 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −8 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −7 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −6 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −5 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −4 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| −3 | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| −2 | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | 2018 | — |
| −1 | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
| 0 (this device) | K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025 | — |
| +2 | K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026 | — |
| +3 | K262149 | corra® cervical plating system | Carlsmed, Inc. | 2026 | — |
| +1 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
| +2 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | — |
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 |
|---|---|---|
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K202064 | Admiral ACP SystemSummary page 4…Name Ma nufacturer Primary Predicate Device SeaSpine Orthopedics K202064 KWQ Admiral ACP System Co… | 2020 |
| * | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSummary page 4…Corporation Additional Predicate Device SeaSpine Cabo ACP (Anterior SeaSpine Orthopedics K173521 KWQ Cervical Plate) System Corporation… | 2018 |
What descends from it? (6)
3 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 29 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 35 ancestors have a recall of any class.
- Of its descendants, K252611 (Carlsmed, Inc., 2025) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K202064.
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. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212139: Admiral ACP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212139
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