510(k) · Cleared
ClearedThoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate, Model 1208-41FXXS
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 Jun 4, 2009 as substantially equivalent to K081380 (K2m, Inc., 2008) and 6 other predicates after a 36-day review. Its family tree reaches back 4 generations to 1998. 73 later devices descend from it.
- Decided
- Jun 4, 2009
- Review
- 36 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K983583 (1998). 19 ancestors in all, the oldest K922543 (1993). 73 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 3 generations backK994347 Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
- 2 generations backK073437 Thor Anterior Plating SystemStryker Spine · 2008 · Recalled
- 1 generation backK080773 Thor Anterior Plating SystemStryker Spine · 2008
- This deviceK091253 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
- Descendant · 2 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 3 generations on · 13 of its ownK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- 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
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 2 generations on15descendants
- K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −3 | K994347 | Centaur Spinal System | Howmedica Osteonics Corp. | 2000 | — |
| −2 | K073437 | Thor Anterior Plating System | Stryker Spine | 2008 | 31 |
| −1 | K080773 | Thor Anterior Plating System | Stryker Spine | 2008 | — |
| 0 (this device) | 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 | — |
| +2 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +3 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K081380 | Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone ScrewsSummary page 1…bral body fixation orthosis (21 CFR 888.3060) 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Cayman Thoracolumbar Plate System, K08 1380 * Blackstone Medical Unity Anterior Lumbar Plate Fixation System, K043 548 * Synthes Thoracolumbar Spine Locking Plate, K… | 2008 |
| * | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation SystemSummary page 1…d devices which are substantially equivalent: * K2M Cayman Thoracolumbar Plate System, K08 1380 * Blackstone Medical Unity Anterior Lumbar Plate Fixation System, K043 548 * Synthes Thoracolumbar Spine Locking Plate, K020244 * Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K0… | 2005 |
| * | K020244 | Synthes Thoracolumbar Spine Locking Plate (TSLP)Summary page 1…yman Thoracolumbar Plate System, K08 1380 * Blackstone Medical Unity Anterior Lumbar Plate Fixation System, K043 548 * Synthes Thoracolumbar Spine Locking Plate, K020244 * Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K013665 * Sofamor Danek Z-Plate, K922543 * Stryker… | 2002 |
| * | K013665 | Pyramid Anterior Plate Fixation SystemSummary page 1…ior Lumbar Plate Fixation System, K043 548 * Synthes Thoracolumbar Spine Locking Plate, K020244 * Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K013665 * Sofamor Danek Z-Plate, K922543 * Stryker Thor Anterior Plating System, K080773 * Theken BodyForm Thoracic Fixation… | 2002 |
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 1…3 548 * Synthes Thoracolumbar Spine Locking Plate, K020244 * Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K013665 * Sofamor Danek Z-Plate, K922543 * Stryker Thor Anterior Plating System, K080773 * Theken BodyForm Thoracic Fixation System, K072407 4. Description of th… | 1993 |
| * | K080773 | Thor Anterior Plating SystemSummary page 1…e, K020244 * Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K013665 * Sofamor Danek Z-Plate, K922543 * Stryker Thor Anterior Plating System, K080773 * Theken BodyForm Thoracic Fixation System, K072407 4. Description of the 'device: The Cayman Thoracolumbar Plate S… | 2008 |
| * | K072407 | Bodyform Thoracic Fixation SystemSummary page 1…r Plate Fixation System, K013665 * Sofamor Danek Z-Plate, K922543 * Stryker Thor Anterior Plating System, K080773 * Theken BodyForm Thoracic Fixation System, K072407 4. Description of the 'device: The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of scre… | 2007 |
What descends from it? (73)
See all 731 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131533 | Cayman MI Plate System | 2013 | 72 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K131533 (K2m, Inc., 2013) has gone furthest, with 72 descendants of its own.
- 3 other devices also cite its predicate K081380.
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. 2009, 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 (Ti-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in…
Read the full statement (148 words)
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (Ti-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: 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) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091253 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091253: Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate, Model 1208-41FXXS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091253
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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