510(k) · Cleared
ClearedPalisades™ Buttress Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bethesda Medical Devices, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 16, 2026 as substantially equivalent to K143065 (Nu Vasive, Incorporated, 2015) after an 86-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jul 16, 2026
- Review
- 86 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922543 (1993). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 5 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
- 3 generations backK111866 Nuvasive Anterior Lumbar Plate SystemNuvasive, Inc. · 2011
- 2 generations backK121837 Nuvasive Brigade Anterior Plate SystemNuvasive, Inc. · 2012
- 1 generation backK143065 NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015
- This deviceK261309 Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −5 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K052546 | Aegis Anterior Lumbar Plate System | Depuy Spine, Inc. | 2006 | — |
| −3 | K111866 | Nuvasive Anterior Lumbar Plate System | Nuvasive, Inc. | 2011 | — |
| −2 | K121837 | Nuvasive Brigade Anterior Plate System | Nuvasive, Inc. | 2012 | — |
| −1 | K143065 | NuVasive ALIF Buttress Plate System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 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 |
|---|---|---|---|
| * | K143065 | NuVasive ALIF Buttress Plate SystemSummary page 5…888.3060 Product Code(s) KWQ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K143065 NuVasive ALIF Buttress Plate System KWQ Device Description Summary 21 CFR 807.92(a)(4) The Palisades™ Buttress Plate System cons… | 2015 |
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 33 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 19 ancestors has 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 Palisades™ Buttress Plate System is a non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The Palisades™ Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and 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/K261309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261309: Palisades™ 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/K261309
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026