510(k) · Cleared
ClearedCastleLoc-P Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 21, 2019 as substantially equivalent to K143271 (L&K BIOMED Co., Ltd., 2015) after a 27-day review. Its family tree reaches back 4 generations to 2000. 13 later devices descend from it.
- Decided
- Mar 21, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K994239 (2000). 6 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
- 3 generations backK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006
- 2 generations backK113509 Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK143271 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK190425 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2019
- Descendant · cites it directly · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · 2 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK223521 ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · cites it directly10descendants
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 2 generations on6descendants
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · cites it directly3descendants
- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · cites it directly2descendants
- K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994239 | Zephir Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −3 | K061002 | Maxima Anterior Cervical Plate System | U&I Corp. | 2006 | — |
| −2 | K113509 | Lexus Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K143271 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2015 | — |
| 0 (this device) | K190425 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2019 | — |
| +1 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +2 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| +1 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| +1 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| +2 | K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K143271 | CastleLoc-P Anterior Cervical Plate SystemSummary page 4…KWQ 3. Purpose of 510(k) L&K BIOMED Co. Ltd., is submitting this Special 510(k) to add new components to own 510(k)-cleared device (K143271) 4. The name of the legally marketed (unmodified) device „ K143271 CastleLoc-P Anterior Cervical Plate System (primar… | 2015 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix… | 2021 | 10 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | 2023 | 3 |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | 2023 | 2 |
| K202878 | Prase-AP Anterior Cervical Plate System | 2021 | 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 19 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K210035 (Aegis Spine, 2021) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K143271.
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. 2019, 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 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
trauma (i.e. fractures or dislocations),
tumors,
deformity (defined as kyphosis, lordosis, or scoliosis),
pseudoarthrosis,
failed previous fusion,
spinal stenosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190425: CastleLoc-P Anterior 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/K190425
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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