510(k) · Cleared
ClearedZavation Buttress Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 27, 2018 as substantially equivalent to K081770 (Omni Surgical, L.P., 2009) and 2 other predicates after a 27-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 27, 2018
- Review
- 27 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K971730 (1997). 13 ancestors in all, the oldest K953730 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 4 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- 3 generations backK042317 Cervical PlateScient'X · 2004
- 2 generations backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
- 1 generation backK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- This deviceK180537 Zavation Buttress Plate SystemZavation Medical Products, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −4 | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| −3 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| −2 | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | 1 |
| −1 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| 0 (this device) | K180537 | Zavation Buttress Plate System | Zavation Medical Products, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K081770 | Black Widow Anterior Buttress PlateSummary page 4…ations. Materials: The Zavation Buttress Plate System components are manufactured from titanium alloy (Ti-6Al- 4V) as described by ASTM F136. Primary Predicate Device: K081770 Black Widow Anterior Buttress Plate System [Spinal Elements]… | 2009 |
| * | K061482 | Altes Buttress Plating SystemSummary page 5…K180537 page 2 of 2 Additional Predicate Devices: K061482 Altes Anterior Buttress Plating System [Exactech Spine] K112533 Zavation Cervical Plate System [Zavation] Technological Characte… | 2006 |
| * | K112533 | Zavation Cervical Plate SystemSummary page 5…page 2 of 2 Additional Predicate Devices: K061482 Altes Anterior Buttress Plating System [Exactech Spine] K112533 Zavation Cervical Plate System [Zavation] Technological Characteristics: The Zavation Buttress Plate System possesses the same t… | 2011 |
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 21 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K081770.
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. 2018, 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 Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180537: Zavation Buttress 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/K180537
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