510(k) · Cleared
ClearedKimba Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 10, 2008 after a 28-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Mar 10, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK080349 Kimba MiniSignus Medizintechnik GmbH · 2008
- Descendant · cites it directly · 8 of its ownK100305 Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09…Icotec · 2011
- Descendant · 2 generations on · 5 of its ownK172480 icotec Interbody Cage SystemIcotec AG · 2018
- Descendant · 3 generations on · 2 of its ownK193378 CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK203683 CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK192897 icotec Cervical CageIcotec AG · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec · 2011 · cites it directly8descendants
- K172480icotec Interbody Cage SystemIcotec AG · 2018 · 2 generations on5descendants
- K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020 · 3 generations on2descendants
- K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021 · 3 generations on1descendant
- K192897icotec Cervical CageIcotec AG · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080349 | Kimba Mini | Signus Medizintechnik GmbH | 2008 | — |
| +1 | K100305 | Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13… | Icotec | 2011 | — |
| +2 | K172480 | icotec Interbody Cage System | Icotec AG | 2018 | — |
| +3 | K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +3 | K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics, Ltd. | 2021 | — |
| +3 | K192897 | icotec Cervical Cage | Icotec AG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | KIMBA mini 023 Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100305 | Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and… | 2011 | 8 |
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, K100305 (Icotec, 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The KIMBA TM mini Spinal Implant is intended for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the lumbar spine and is intended for use with supplemental internal fixation. The KIMBA TM mini is intended to be implanted singularly.
The supplemental internal fixation systems that may be used with the KIMBA TM mini spinal implant include, but are not limited to, SIGNUS Conklusion rod system, DePuy AcroMed titaniun plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080349 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080349: Kimba Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080349
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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