510(k) · Cleared
ClearedZero Profile Anterior Cervical Plate (Acp) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 22, 2007 as substantially equivalent to K062310 (Stryker Spine, 2006) and 3 other predicates after a 129-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 22, 2007
- Review
- 129 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K000536 (2000). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
- 1 generation backK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
- This deviceK063430 Zero Profile Anterior Cervical Plate (Acp) SystemStryker Spine · 2007
- Descendant · cites it directly · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
Most influential descendants
Showing 2 of 2 · See all- K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · cites it directly1descendant
- K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000536 | Synthes Anterior CSLP System | Synthes Spine | 2000 | 1 |
| −1 | K062310 | Reflex Hybrid Acp System | Stryker Spine | 2006 | 2 |
| 0 (this device) | K063430 | Zero Profile Anterior Cervical Plate (Acp) System | Stryker Spine | 2007 | — |
| +1 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
| +2 | K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical… | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K062310 | Reflex Hybrid Acp SystemSummary page 1…c stryker. com Date Summary Prepared: February 28, 2007 Predicate Device ReflexTM Hybrid ACP System (K0623 10, K04026 1) Synthes Cervical Spine Locking Plate System… | 2006 |
| * | K040261 | Reflex Hybrid Anterior Cervical Plate SystemSummary page 1…com Date Summary Prepared: February 28, 2007 Predicate Device ReflexTM Hybrid ACP System (K0623 10, K04026 1) Synthes Cervical Spine Locking Plate System… | 2004 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 1…(K0623 10, K04026 1) Synthes Cervical Spine Locking Plate System (K000536 and K000742) 1… | 2000 |
| * | K000742 | Synthes Anterior CSLP SystemSummary page 1…04026 1) Synthes Cervical Spine Locking Plate System (K000536 and K000742) 1… | 2000 |
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 |
|---|---|---|---|
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior… | 2022 | 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K221728 (Stryker Corporation, 2022) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K062310.
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. 2007, 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 Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-TI. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and…
Read the full statement (131 words)
The Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-TI. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
* Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
* Trauma (including fractures)
* Tumors
* Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
* Pseudarthrosis
* Failed previous fusion
* Decompression of the spinal cord following total or partial cervical vertebrectomy
* Spondylolisthesis
* Spinal stenosis
WARNING: This device is not approved or intended for screw attachment 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/K063430 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063430: Zero Profile Anterior Cervical Plate (Acp) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063430
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