510(k) · Cleared
ClearedVyPlate™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vy Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 27, 2026 as substantially equivalent to K221572 (Vy Spine, LLC, 2022) after a 23-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Mar 27, 2026
- Review
- 23 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K922087 (1992). 43 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations between
- 3 generations backK122216 Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012
- 2 generations backK140742 Reliance Anterior Cervical PlateReliance Medical Systems, LLC · 2014
- 1 generation backK221572 VyPlate Anterior Cervical Plate SystemVy Spine, LLC · 2022
- This deviceK260697 VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026
Show all 10 generations
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 9 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 8 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 7 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 6 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 5 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 4 generations backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- 3 generations backK122216 Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012
- 2 generations backK140742 Reliance Anterior Cervical PlateReliance Medical Systems, LLC · 2014
- 1 generation backK221572 VyPlate Anterior Cervical Plate SystemVy Spine, LLC · 2022
- This deviceK260697 VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −9 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −8 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −7 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −6 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −5 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −4 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| −3 | K122216 | Reliance Anterior Cervical Plate System | Reliance Medical Systems, LLC | 2012 | — |
| −2 | K140742 | Reliance Anterior Cervical Plate | Reliance Medical Systems, LLC | 2014 | — |
| −1 | K221572 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | 2022 | — |
| 0 (this device) | K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K221572 | VyPlate Anterior Cervical Plate SystemSummary page 5…ation Orthosis Regulation Number: 21 CFR 888.3060 Product Code: KWQ Primary Predicate: K221572 VyPlate™ Anterior Cervical Plate System Substantial Equivalence The VyPlate™ Anterior Cervical Plate System is substantially equ… | 2022 |
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 34 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 43 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. 2026, 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 VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: • instability caused by trauma or fracture; • instability associated with correction of cervical lordosis and kyphosis deformity; • instability associated with pseudoarthosis as a result of…
Read the full statement (145 words)
The VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
• instability caused by trauma or fracture;
• instability associated with correction of cervical lordosis and kyphosis deformity;
• instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260697 · printed Nov 3, 2026
Cite this page
510(k) Report. “K260697: VyPlate™ Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260697
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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