510(k) · Cleared
ClearedThoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws
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 Nov 19, 2008 after a 187-day review. The FDA summary names its predicate without a number. 75 later devices descend from it.
- Decided
- Nov 19, 2008
- Review
- 187 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
75 later devices descend from it, 4 citing it directly.
- This deviceK081380 Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone ScrewsK2m, Inc. · 2008
- Descendant · cites it directly · 73 of its ownK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
- Descendant · cites it directly · 73 of its ownK091253 Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model…K2m, Inc. · 2009
- Descendant · cites it directly · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
- Descendant · 3 generations on · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010 · cites it directly73descendants
- K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc. · 2009 · cites it directly73descendants
- K131533Cayman MI Plate SystemK2m, Inc. · 2013 · cites it directly72descendants
- K172941CASCADIA Interbody SystemK2m · 2018 · 2 generations on52descendants
- K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081380 | Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws | K2m, Inc. | 2008 | — |
| +1 | K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX | K2m, Inc. | 2010 | — |
| +1 | K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral… | K2m, Inc. | 2009 | — |
| +1 | K131533 | Cayman MI Plate System | K2m, Inc. | 2013 | — |
| +2 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| +3 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 14 | 0 |
| 2024 | 11 | 0 |
| 2025 | 13 | 0 |
| 2026 | 12 | 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? (4)
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 |
|---|---|---|---|
| * | — | Blackstone Medical Unity Anterior Lumbar Plate Fixation System Named without a submission number | |
| * | — | Synthes Thoracolumbar Spine Locking Plate Named without a submission number | |
| * | — | Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System Named without a submission number | |
| * | — | Sofamor Danek Z-Plate Named without a submission number |
What descends from it? (75)
See all 754 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX | 2010 | 73 |
| K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate… | 2009 | 73 |
| K131533 | Cayman MI Plate System | 2013 | 72 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System… | 2024 | 1 |
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, K100061 (K2m, Inc., 2010) has gone furthest, with 73 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 Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: a)…
Read the full statement (150 words)
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) idiopathic thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele, k) neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081380: Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081380
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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