KIMBA
SIGNUS Medizintechnik GmbH · Model Lumbar cage · UDI-DI 04047844005774
Description
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-10-29 | Medicrea International | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| 2025-10-29 | Medicrea International | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| 2025-09-16 | Medtronic Sofamor Danek USA Inc | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical techni |
| 2025-08-06 | SEASPINE ORTHOPEDICS CORPORATION | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may le |
| 2025-06-24 | Orthofix U.S. LLC | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap infor |
| 2025-02-20 | Orthofix U.S. LLC | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. |
| 2024-12-15 | Alphatec Spine, Inc. | Complaints have been received regarding post-operative implant collapse. |
| 2024-08-14 | Innovasis, Inc | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
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