510(k) · Cleared
ClearedKASILOF Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kahtnu Surgical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 5, 2020 as substantially equivalent to K173867 (Axis Orthopaedics, 2018) and 1 other predicate after a 14-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Nov 5, 2020
- Review
- 14 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K031276 (2003). 14 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 6 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 5 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- 4 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- 3 generations backK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
- 2 generations backK143576 Exactech AmbassadorExactech, Inc. · 2015 · Recalled
- 1 generation backK173867 Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018
- This deviceK203154 KASILOF Cervical Plate SystemKahtnu Surgical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −5 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| −4 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| −3 | K071667 | Synthes Vectra-One System | Synthes Spine | 2007 | 3 |
| −2 | K143576 | Exactech Ambassador | Exactech, Inc. | 2015 | 1 |
| −1 | K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | 2018 | — |
| 0 (this device) | K203154 | KASILOF Cervical Plate System | Kahtnu Surgical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K173867 | Axis Anterior Cervical Plate SystemSummary page 5…lly equivalent to the following predicate devices: Primary Predicate: • KASILOF Cervical Plates (Previously known as Axis Anterior Cervical Plate System) - K173867 Secondary Predicates: • Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) The subject four and five lev… | 2018 |
| * | K021461 | Atlantis Vision Anterior Cervical Plate SystemSummary page 5…lates (Previously known as Axis Anterior Cervical Plate System) - K173867 Secondary Predicates: • Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) The subject four and five level plates are to be used in the stabilization of the anterior cervical spine during the developme… | 2002 |
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 17 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 14 ancestors have a recall of any class.
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. 2020, 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 KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203154: KASILOF Cervical 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/K203154
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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