510(k) · Cleared
ClearedWindow Cervical Dynamic Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Spine Technology, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 7, 2000 after a 349-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.
- Decided
- Jun 7, 2000
- Review
- 349 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK993066 Window Cervical Dynamic Plate SystemAdvanced Spine Technology, Inc. · 2000
- Descendant · cites it directly · 26 of its ownK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- Descendant · 2 generations on · 15 of its ownK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
- Descendant · 2 generations on · 7 of its ownK181244 Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018
- Descendant · 3 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · 3 generations on · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K112533Zavation Cervical Plate SystemZavation, LLC · 2011 · cites it directly26descendants
- K130030Zavation Cervical Plate SystemZavation, LLC · 2013 · 2 generations on15descendants
- K181244Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018 · 2 generations on7descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 3 generations on6descendants
- K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993066 | Window Cervical Dynamic Plate System | Advanced Spine Technology, Inc. | 2000 | — |
| +1 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| +2 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
| +2 | K181244 | Zavation Cervical Plate System | Zavation Medical Products, LLC | 2018 | — |
| +3 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +3 | K172104 | Ozark (tm) Cervical Plate System | K2m, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | — | ORION Cervical Spinal System Named without a submission number |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112533 | Zavation Cervical Plate System | 2011 | 26 |
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?
- Of its descendants, K112533 (Zavation, LLC, 2011) has gone furthest, with 26 descendants of its own.
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.
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 Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), trauma (including fractures), tumors…
Read the full statement (103 words)
The Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.
Warning: 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993066: Window Cervical Dynamic Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993066
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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