510(k) · Cleared
Recalled · 2008Reflex Hybrid Anterior Cervical Plate 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 Apr 16, 2004 after a 72-day review. The FDA summary names its predicate without a number. 51 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 16, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 4
- Predicates
- 0
51 later devices descend from it, 9 citing it directly.
- This deviceK040261 Reflex Hybrid Anterior Cervical Plate SystemStryker Spine · 2004
- Descendant · cites it directly · 27 of its ownK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- Descendant · 2 generations on · 25 of its ownK053053 Pacp SystemPioneer Surgical Technology · 2005
- Descendant · cites it directly · 22 of its ownK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
- Descendant · 3 generations on · 19 of its ownK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- Descendant · 2 generations on · 17 of its ownK083663 PACPPioneer Surgical Technology · 2009
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005 · cites it directly27descendants
- K053053Pacp SystemPioneer Surgical Technology · 2005 · 2 generations on25descendants
- K062310Reflex Hybrid Acp SystemStryker Spine · 2006 · cites it directly22descendants
- K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008 · 3 generations on19descendants
- K083663PACPPioneer Surgical Technology · 2009 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040261 | Reflex Hybrid Anterior Cervical Plate System | Stryker Spine | 2004 | — |
| +1 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| +2 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| +1 | K062310 | Reflex Hybrid Acp System | Stryker Spine | 2006 | 2 |
| +3 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| +2 | K083663 | PACP | Pioneer Surgical Technology | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | — | Reflex Anterior Cervical Plate System Named without a submission number |
What descends from it? (51)
See all 519 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043066 | Pioneer Anterior Cervical Plate System | 2005 | 27 |
| K062310 | Reflex Hybrid Acp System | 2006 | 22 |
| K083562 | Stryker Spine Nulock Anterior Cervical Plating System | 2009 | 16 |
| K142237 | Aviator Anterior Cervical Plate (ACP) System | 2015 | 9 |
| K083020 | Stryker Spine Reflex Translational Anterior Cervical Plating System | 2009 | 3 |
| K063430 | Zero Profile Anterior Cervical Plate (Acp) System | 2007 | 2 |
| K170342 | Ocata Anterior Cervical System | 2017 | 1 |
| K200883 | CarboClear® Cervical Plate System | 2020 | 0 |
| K100215 | Archimed Remedy Cervical Plate | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2008 | Not classified | Z-0217-2009 | Nonconforming Material/Component | The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw. |
| Jun 14, 2006 | Not classified | Z-1958-2009 | Device Design | Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used. |
| Jun 14, 2006 | Not classified | Z-1960-2009 | Device Design | Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used. |
| Jun 14, 2006 | Not classified | Z-1959-2009 | Device Design | Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043066 (Pioneer Surgical Technology, 2005) has gone furthest, with 27 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.
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 Reflex TM Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. 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 history and radiographic studies) Trauma…
Read the full statement (96 words)
The Reflex TM Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. 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 history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis or scoliosis)
Pseudoarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy.
Spondylolisthesis
Spinal Stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040261 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040261: Reflex Hybrid Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040261
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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