510(k) · Cleared
ClearedAnterior Lumbar Buttress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 26, 2004 as substantially equivalent to K021039 (Depuyacromed, 2002) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it.
- Decided
- Mar 26, 2004
- Review
- 65 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926453 (1993). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 1 generation backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
- This deviceK040130 Anterior Lumbar Buttress SystemSeaspine · 2004
- Descendant · cites it directly · 1 of its ownK143065 NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 1 of its ownK073349 Reliance Buttress Washer SystemReliance Medical Systems, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK261309 Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK213219 Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015 · cites it directly1descendant
- K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC · 2008 · cites it directly1descendant
- K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026 · 2 generations on0descendants
- K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −1 | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps) | Synthes (Usa) | 1997 | — |
| 0 (this device) | K040130 | Anterior Lumbar Buttress System | Seaspine | 2004 | — |
| +1 | K143065 | NuVasive ALIF Buttress Plate System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K073349 | Reliance Buttress Washer System | Reliance Medical Systems, LLC | 2008 | — |
| +2 | K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026 | — |
| +2 | K213219 | Vy Spine™ VyWasher™ Buttress System | Vy Spine, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K021039 | Bowti Anterior Buttress Staple SystemSummary page 1…Anterior Lumbar Buttress System The primary devices used for comparison in this summary are DePuy AcroMedTM , Inc.'s Bow Ti Anterior Buttress Staple System (K021039) and Synthes' Synthes Titanium Locking Plate System (K970048). 1. Intended Use: (The statements of intended use a… | 2002 |
| * | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps)Summary page 1…ed for comparison in this summary are DePuy AcroMedTM , Inc.'s Bow Ti Anterior Buttress Staple System (K021039) and Synthes' Synthes Titanium Locking Plate System (K970048). 1. Intended Use: (The statements of intended use are identical.) The intended use of the Anterior Lumbar Buttr… | 1997 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K143065 (Nu Vasive, Incorporated, 2015) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K021039.
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 Anterior Lumbar Buttress System is intended for anterior intravertebral body screw
fixation/attachment to the LI -SI spine over one vertebral body extending onto the
adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for
applications caudal to the bifurcation of the great vessels. Specifically, the device is
intended for stabilization and buttressing of bone graft over one motion segment
following anterior structural reconstruction for degenerative disc disease (DDD). DDD is
defined as follows: back pain of a discogenic origin with degeneration of the disc
confinned by history and radiographic studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040130: Anterior Lumbar Buttress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040130
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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