510(k) · Cleared
ClearedPrase-AP Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gbs Commonwealth Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 29, 2021 as substantially equivalent to K190425 (L&K BIOMED Co., Ltd., 2019) after a 123-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jan 29, 2021
- Review
- 123 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K994239 (2000). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
- 4 generations backK061002 Maxima Anterior Cervical Plate SystemU&I Corp. · 2006
- 3 generations backK113509 Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK143271 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2015
- 1 generation backK190425 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2019
- This deviceK202878 Prase-AP Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994239 | Zephir Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −4 | K061002 | Maxima Anterior Cervical Plate System | U&I Corp. | 2006 | — |
| −3 | K113509 | Lexus Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K143271 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2015 | — |
| −1 | K190425 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2019 | — |
| 0 (this device) | K202878 | Prase-AP Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021 | — |
| +1 | K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021 | — |
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 | 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? (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 |
|---|---|---|---|
| * | K190425 | CastleLoc-P Anterior Cervical Plate SystemSummary page 4…roduction of Prase-AP Anterior Cervical Plate System 3. Predicate or legally marketed devices which are substantially equivalent 1) Primary Predicate Device: : K190425 CastleLoc-P Anterior Cervical Plate System… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211205 | Prase-C Anterior Cervical Plate System | 2021 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K211205 (Gbs Commonwealth Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K190425.
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. 2021, 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 Prase-AP 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 as stated in the FDA summary.
https://510kreport.com/device/K202878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202878: Prase-AP 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/K202878
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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