510(k) · Cleared
ClearedCayman MI 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 Nov 9, 2013 as substantially equivalent to K081380 (K2m, Inc., 2008) and 5 other predicates after a 168-day review. Its family tree reaches back 7 generations to 1999. 72 later devices descend from it.
- Decided
- Nov 9, 2013
- Review
- 168 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K990745 (1999). 41 ancestors in all, the oldest K873826 (1988). 72 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 5 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 4 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 3 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 2 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 1 generation backK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
- This deviceK131533 Cayman MI Plate SystemK2m, Inc. · 2013
- Descendant · cites it directly · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
- Descendant · 2 generations on · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- Descendant · cites it directly · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 13 of its ownK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- Descendant · 3 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K172941CASCADIA Interbody SystemK2m · 2018 · cites it directly52descendants
- K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · 2 generations on24descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · cites it directly15descendants
- K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019 · 2 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −6 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −5 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −4 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −3 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −2 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −1 | K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX | K2m, Inc. | 2010 | — |
| 0 (this device) | K131533 | Cayman MI Plate System | K2m, Inc. | 2013 | — |
| +1 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| +2 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| +1 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| +3 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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…orthosis (21 CFR 888.3060) Product Code: KWQ 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Cayman Plate System. K(081380, K091253, K(100061 * DePuy Aegis. K(052546 * DePuy M2, K972718 * Sofamor Danek. Z-Plate, K(922543 4. Description… | 2008 |
| * | K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…Summary page 1…(21 CFR 888.3060) Product Code: KWQ 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Cayman Plate System. K(081380, K091253, K(100061 * DePuy Aegis. K(052546 * DePuy M2, K972718 * Sofamor Danek. Z-Plate, K(922543 4. Description of the de… | 2009 |
| * | K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXSummary page 1…8.3060) Product Code: KWQ 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Cayman Plate System. K(081380, K091253, K(100061 * DePuy Aegis. K(052546 * DePuy M2, K972718 * Sofamor Danek. Z-Plate, K(922543 4. Description of the device:… | 2010 |
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 1…KWQ 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Cayman Plate System. K(081380, K091253, K(100061 * DePuy Aegis. K(052546 * DePuy M2, K972718 * Sofamor Danek. Z-Plate, K(922543 4. Description of the device: The Cayman Plate System… | 2006 |
| * | K972718 | M-2 Anterior Plate SystemSummary page 1…or legally marketed devices which are substantially equivalent: " K2M Cayman Plate System. K(081380, K091253, K(100061 * DePuy Aegis. K(052546 * DePuy M2, K972718 * Sofamor Danek. Z-Plate, K(922543 4. Description of the device: The Cayman Plate System is a spinal fixation syst… | 1997 |
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 1…stantially equivalent: " K2M Cayman Plate System. K(081380, K091253, K(100061 * DePuy Aegis. K(052546 * DePuy M2, K972718 * Sofamor Danek. Z-Plate, K(922543 4. Description of the device: The Cayman Plate System is a spinal fixation system which consists of screws and plates.… | 1993 |
What descends from it? (72)
See all 724 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 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 41 ancestors have a recall of any class.
- Of its descendants, K172941 (K2m, 2018) has gone furthest, with 52 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. 2013, 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 Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografis; or autografts. The device is not intended for load bearing indications. The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (TI-L-5) spine and for use as an anteriorly placed supplemental fixation…
Read the full statement (183 words)
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografis; or autografts. The device is not intended for load bearing indications.
The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (TI-L-5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S 1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph 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, hi) Jordotic 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/K131533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131533: Cayman MI 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/K131533
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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