510(k) · Cleared
ClearedCayman Buttress Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 24, 2008 after a 48-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 24, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK080302 Cayman Buttress Plate SystemK2m, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK190584 CAYMAN LP Plate SystemK2m, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 3 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK081418 Spinal Elements Buttress Plate SystemSpinal Elements, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K190584CAYMAN LP Plate SystemK2m, Inc. · 2019 · cites it directly2descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 3 generations on0descendants
- K081418Spinal Elements Buttress Plate SystemSpinal Elements, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080302 | Cayman Buttress Plate System | K2m, Inc. | 2008 | — |
| +1 | K190584 | CAYMAN LP Plate System | K2m, Inc. | 2019 | — |
| +2 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +3 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
| +1 | K081418 | Spinal Elements Buttress Plate System | Spinal Elements, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | — | Seaspine Anterior Lumbar Buttress System Named without a submission number | |
| * | — | BowTi Anterior Staple System Named without a submission number | |
| * | — | Synthes Titanium Locking Plate System Named without a submission number | |
| * | — | Altiva Buttress Plating System Named without a submission number | |
| * | — | Medtronic Sofiamor Danek Bone Graft Washer Named without a submission number |
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?
- Of its descendants, K190584 (K2m, Inc., 2019) has gone furthest, with 2 descendants of its own.
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. 2008, 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 Cayman 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/K080302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080302: Cayman 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/K080302
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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