510(k) · Cleared
ClearedGenesys Spine Anterior Buttress Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesys Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 3, 2014 as substantially equivalent to K081770 (Omni Surgical, L.P., 2009) and 2 other predicates after a 254-day review. Its family tree reaches back 2 generations to 2001. 16 later devices descend from it.
- Decided
- Sep 3, 2014
- Review
- 254 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010911 (2001). 4 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 1 generation backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- This deviceK133911 Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014
- Descendant · cites it directly · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- Descendant · 2 generations on · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
- Descendant · 2 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- Descendant · 2 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- Descendant · 3 generations on · 2 of its ownK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · cites it directly14descendants
- K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021 · 2 generations on6descendants
- K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · 2 generations on5descendants
- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 2 generations on3descendants
- K240126ProAM ALIF SystemPro Surgical, Inc. · 2024 · 3 generations on2descendants
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 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| 0 (this device) | K133911 | Genesys Spine Anterior Buttress Plate System | Genesys Spine | 2014 | — |
| +1 | K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 | — |
| +2 | K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | 2021 | — |
| +2 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 | — |
| +2 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| +3 | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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? (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 5…ce data lead to the conclusion that the Genesys Spine Anterior Buttress Plate System is substantially equivalent to the Black Widow Anterior Buttress Plate (Omni Spine - K081770), BOWTI Anterior Buttress Staple System (Depuy Acromed – K021039), and Butrex Buttress Plating System (X-Spine, Inc. - K072943).… | 2009 |
| * | K021039 | Bowti Anterior Buttress Staple SystemSummary page 5…ttress Plate System is substantially equivalent to the Black Widow Anterior Buttress Plate (Omni Spine - K081770), BOWTI Anterior Buttress Staple System (Depuy Acromed – K021039), and Butrex Buttress Plating System (X-Spine, Inc. - K072943). | 2002 |
| * | K072943 | Butrex Buttress Plating SystemSummary page 5…idow Anterior Buttress Plate (Omni Spine - K081770), BOWTI Anterior Buttress Staple System (Depuy Acromed – K021039), and Butrex Buttress Plating System (X-Spine, Inc. - K072943). | 2008 |
What descends from it? (16)
See all 162 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 13 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K192006 (Astura Medical, LLC, 2020) has gone furthest, with 14 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. 2014, 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 Genesys Spine Anterior 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 or autografts. This device is not intended for load bearing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133911: Genesys Spine Anterior 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/K133911
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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