510(k) · Cleared
ClearedCayman Screws Model K2-12-1000-XX, K2-12-1001-XX
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 Feb 12, 2010 as substantially equivalent to K081380 (K2m, Inc., 2008) and 4 other predicates after a 32-day review. Its family tree reaches back 6 generations to 1999. 73 later devices descend from it.
- Decided
- Feb 12, 2010
- Review
- 32 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K990745 (1999). 21 ancestors in all, the oldest K873826 (1988). 73 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 4 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 3 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 2 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 1 generation backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- This deviceK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
- 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 |
|---|---|---|---|---|---|
| −6 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −5 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −4 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −3 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −2 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −1 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| 0 (this device) | K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX | K2m, Inc. | 2010 | — |
| +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 |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K081380 | Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone ScrewsSummary page 1…888.3060) Product Code: KWQ 3. Predicate or legally marketed devices which are substantially equivalent • K2M Cayman Thoracolumnbar Plate System, K081380 * DePuy Kaneda SR, K971248 * Synthes VentroFix, K031 I100 * Globus Medical Gateway, K062407 * Medtronic Sofamor D… | 2008 |
| * | K971248 | Kaneda SR Anterior Spinal SystemSummary page 1…KWQ 3. Predicate or legally marketed devices which are substantially equivalent • K2M Cayman Thoracolumnbar Plate System, K081380 * DePuy Kaneda SR, K971248 * Synthes VentroFix, K031 I100 * Globus Medical Gateway, K062407 * Medtronic Sofamor Danek Z-Plate II, K922543 4. De… | 1997 |
| * | K031100 | Synthes Ventrofix Mis System | 2004 |
| * | K062407 | Gateway Thoracolumbar Plate SystemSummary page 1…antially equivalent • K2M Cayman Thoracolumnbar Plate System, K081380 * DePuy Kaneda SR, K971248 * Synthes VentroFix, K031 I100 * Globus Medical Gateway, K062407 * Medtronic Sofamor Danek Z-Plate II, K922543 4. Description of the device: The Cayman Thoracolumbar Plate System i… | 2006 |
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 1…r Plate System, K081380 * DePuy Kaneda SR, K971248 * Synthes VentroFix, K031 I100 * Globus Medical Gateway, K062407 * Medtronic Sofamor Danek Z-Plate II, K922543 4. Description of the device: The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screw… | 1993 |
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 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 21 ancestors has 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. 2010, 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 PLATES are 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 - SI1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in…
Read the full statement (149 words)
The CAYMAN THORACOLUMBAR PLATES are 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 - SI1). 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, 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 laminiectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100061 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100061: Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100061
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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