510(k) · Cleared
ClearedChoice Spine Anterior Cervical Plate (Acp) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 22, 2009 after a 175-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Dec 22, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK091926 Choice Spine Anterior Cervical Plate (Acp) SystemChoicespine, LP · 2009
- Descendant · cites it directly · 1 of its ownK173867 Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018
- Descendant · 2 generations on · 0 of its ownK203154 KASILOF Cervical Plate SystemKahtnu Surgical, Inc. · 2020
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 |
|---|---|---|---|---|---|
| 0 (this device) | K091926 | Choice Spine Anterior Cervical Plate (Acp) System | Choicespine, LP | 2009 | — |
| +1 | K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | 2018 | — |
| +2 | K203154 | KASILOF Cervical Plate System | Kahtnu Surgical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K173867 | Axis Anterior Cervical Plate System | 2018 | 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?
- Of its descendants, K173867 (Axis Orthopaedics, 2018) has gone furthest, with 1 descendant 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. 2009, 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 Choice Spine Anterior Cervical Plate (ACP) System is intended for anterior screw fixation of the cervical spine (levels C2 to C7) and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include: failed previous fusion, pseudoarthrosis, tumor, deformity, spinal sternosis, trauma, spondylolisthesis, or degenerative disc disease defined as neck pain of disdogenic origin with the…
Read the full statement (107 words)
The Choice Spine Anterior Cervical Plate (ACP) System is intended for anterior screw fixation of the cervical spine (levels C2 to C7) and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include: failed previous fusion, pseudoarthrosis, tumor, deformity, spinal sternosis, trauma, spondylolisthesis, or degenerative disc disease defined as neck pain of disdogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
WARNING: The Choice Spine Anterior Cervical Plate ('ACP) System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091926: Choice Spine Anterior Cervical Plate (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/K091926
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