510(k) · Cleared
ClearedPrase-C 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 Aug 12, 2021 as substantially equivalent to K202878 (Gbs Commonwealth Co., Ltd., 2021) and 2 other predicates after a 112-day review. Its family tree reaches back 18 generations to 2001.
- Decided
- Aug 12, 2021
- Review
- 112 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K003155 (2001). 280 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
- 2 generations backK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- This deviceK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 8 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 7 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 5 generations backK100967 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK132584 Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140417 Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc. · 2014
- 2 generations backK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- This deviceK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −8 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −7 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −5 | K100967 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K132584 | Perimeter C Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140417 | Divergence Mini-Plate Anterior Cervical Fusion System | Medtronic Sofamor Danek, Inc. | 2014 | — |
| −2 | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 12 | 0 |
| 2003 | 22 | 0 |
| 2004 | 27 | 0 |
| 2005 | 18 | 0 |
| 2006 | 13 | 0 |
| 2007 | 14 | 0 |
| 2008 | 20 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K202878 | Prase-AP Anterior Cervical Plate SystemSummary page 4…troduction of Prase-C Anterior Cervical Plate System 3. Predicate or legally marketed devices which are substantially equivalent 1) Primary Predicate Device: : K202878 Prase-C Anterior Cervical Plate System 2) Additional Predicated(s) : (1) K191584 Fortico Anterior Cervical Fixation System… | 2021 |
| * | K191584 | FORTICO Anterior Cervical Fixation SystemSummary page 4…d devices which are substantially equivalent 1) Primary Predicate Device: : K202878 Prase-C Anterior Cervical Plate System 2) Additional Predicated(s) : (1) K191584 Fortico Anterior Cervical Fixation System (2) K182418 V3 Segmental Plating System === Page 5… | 2019 |
| * | K182418 | V3 Segmental Plating SystemSummary page 4…Prase-C Anterior Cervical Plate System 2) Additional Predicated(s) : (1) K191584 Fortico Anterior Cervical Fixation System (2) K182418 V3 Segmental Plating System K21… | 2018 |
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 20 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 28 of the 280 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. 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-C 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/K211205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211205: Prase-C 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/K211205
Report an extraction error
Are you the manufacturer?
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