510(k) · Cleared
ClearedVail ALIF Buttress Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 6, 2018 as substantially equivalent to K081770 (Omni Surgical, L.P., 2009) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jul 6, 2018
- Review
- 106 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010911 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 1 generation backK081770 Black Widow Anterior Buttress PlateOmni Surgical, L.P. · 2009 · Recalled
- This deviceK180755 Vail ALIF Buttress Plate SystemEvolution Spine, LLC · 2018
- Descendant · cites it directly · 0 of its ownK222628 Life Spine ALIF Buttress Plate SystemLife Spine, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −1 | K081770 | Black Widow Anterior Buttress Plate | Omni Surgical, L.P. | 2009 | 2 |
| 0 (this device) | K180755 | Vail ALIF Buttress Plate System | Evolution Spine, LLC | 2018 | — |
| +1 | K222628 | Life Spine ALIF Buttress Plate System | Life Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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…tion name: Spinal intervertebral body fixation orthosis Regulatory Class: Class 11 Product Code: KWQ I1I. PREDICATE DEVICE Black Widow Anterior Buttress Plate System (K081770) - Primary Predicate This predicate has not been subject to a design-related recall Fang Plate System (K090415) This predicate… | 2009 |
| * | K090415 | Eminent Spine Buttress (Fang) Plate SystemSummary page 4…ICATE DEVICE Black Widow Anterior Buttress Plate System (K081770) - Primary Predicate This predicate has not been subject to a design-related recall Fang Plate System (K090415) This predicate has not been subject to a design-related recall IV. DEVICE DESCRIPTION The Vail ALIF Buttress Plate System is… | 2009 |
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 |
|---|---|---|---|
| K222628 | Life Spine ALIF Buttress Plate System | 2022 | 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 17 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K222628 (Life Spine, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 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 Vail ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
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/K180755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180755: Vail ALIF 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/K180755
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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