510(k) · Cleared
ClearedMSFX Mikron Cervical Anterior Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mikron Makina Sanayi VE Ticaret Ltd. Sti. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 17, 2024 as substantially equivalent to K211718 (Artfx Medical, LLC, 2022) and 1 other predicate after a 57-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 17, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000536 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
- 2 generations backK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
- 1 generation backK083562 Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
- This deviceK240484 MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000536 | Synthes Anterior CSLP System | Synthes Spine | 2000 | 1 |
| −2 | K062310 | Reflex Hybrid Acp System | Stryker Spine | 2006 | 2 |
| −1 | K083562 | Stryker Spine Nulock Anterior Cervical Plating System | Stryker Corp. | 2009 | — |
| 0 (this device) | K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K211718 | Venus Cervical Plate SystemSummary page 5…testing including Fatigue Test (ASTM F1717-18) Static Compression Test (ASTM F1717- 18), and Static Torsion Test (ASTM F1717-18) were conducted on the predicate device (K211718). As the purpose of this submission is to rebrand the Venus Cervical Plate System (K211718), no new mechanical testing is needed… | 2022 |
| * | K083562 | Stryker Spine Nulock Anterior Cervical Plating SystemSummary page 6…REGULATION NUMBER: 21 CFR 888.3060 REGULATION NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY REGULATORY CLASS: Class II PRODUCT CODE: KWQ 510(K) NUMBER: K083562 TECHNOLOGICAL CHARACTERISTICS : The MSFX MIKRON CERVICAL ANTERIOR PLATE SYSTEM has similar technological characteristics as th… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K211718.
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. 2024, 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 MSFX Mikron Cervical Anterior Plate 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 patient history and radiographic…
Read the full statement (98 words)
The MSFX Mikron Cervical Anterior Plate 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240484: MSFX Mikron Cervical Anterior Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240484
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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