# K080349: Kimba Mini

- Pathway: 510(k) (Special)
- Applicant: Signus Medizintechnik GmbH
- Decided: Mar 10, 2008 after 28 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KIMBA mini 023: named in the summary without a submission number

## Most influential descendants
- K100305: Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and Eturn XX-12 K; Eturn XX-16 K Wher (2011), 8 descendants of its own
- K172480: icotec Interbody Cage System (2018), 5 descendants of its own
- K193378: CarboClear Lumbar Cage System (2020), 2 descendants of its own
- K203683: CarboClear Lumbar Cage System (2021), 1 descendant of its own
- K192897: icotec Cervical Cage (2020), 1 descendant of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K080349
Methodology: https://510kreport.com/methodology