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Sign in to claim this brandKICO KNEE INNOVATION COMPANY PTY LIMITED
US
Last updated May 24, 2026
What KICO KNEE INNOVATION COMPANY PTY LIMITED makes
The company manufactures reusable orthopaedic instruments and systems for surgical planning and navigation, including positioning instruments for prosthesis implantation, robotic surgical software applications, stereotactic surgery systems, optical-tracking markers, and reusable trays, probes, and bone awls. Their portfolio also includes orthopaedic and craniofacial implantation planning software, designed to assist in precise surgical procedures across orthopaedic, abdominal, and ENT applications.
The devices fall under FDA Class I and Class II classifications, with regulatory submissions documented via 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. The company’s products are listed in the US market, adhering to FDA requirements for medical device authorisation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does KICO Knee Innovation Company Pty Limited manufacture?
KICO Knee Innovation Company Pty Limited specializes in reusable orthopaedic instruments and systems for surgical planning and navigation. Their portfolio includes positioning instruments for prosthesis implantation, robotic surgical navigation software, stereotactic surgery systems, optical-tracking markers, reusable trays, probes, bone awls, and software for orthopaedic and craniofacial implantation planning. These devices are designed to support precision in orthopaedic, abdominal, and ENT surgical procedures.
Where is KICO Knee Innovation Company Pty Limited based?
KICO Knee Innovation Company Pty Limited is based in the United States. The company’s devices are developed and marketed within this region, adhering to US regulatory requirements.
Which regulatory registries or databases list KICO Knee Innovation Company Pty Limited’s devices?
KICO Knee Innovation Company Pty Limited’s devices are documented in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary regulatory submissions for market authorisation in the US.
How are KICO Knee Innovation Company Pty Limited’s devices classified under FDA regulations?
KICO Knee Innovation Company Pty Limited’s devices are classified under FDA categories Class I and Class II. The classification determines the regulatory pathway for market authorisation, with Class I devices generally posing minimal risk and Class II devices requiring premarket notifications (such as 510(k)s) to demonstrate substantial equivalence to existing authorised devices.
What is the purpose of the software applications developed by KICO Knee Innovation Company Pty Limited?
The software applications developed by KICO Knee Innovation Company Pty Limited serve as robotic surgical navigation tools and orthopaedic/craniofacial implantation planning systems. These tools assist surgeons in achieving precise surgical outcomes by providing real-time guidance, spatial tracking, and pre-operative planning tailored to orthopaedic, abdominal, and ENT procedures, enhancing accuracy and efficiency during surgery.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 757918953
Catalogue (169)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arvis ® | IN-12800 | FDA UDI | Class II | Active |
| Arvis ® | 16500 | FDA UDI | Class II | Active |
| Arvis ® | IN-17600 | FDA UDI | Class II | Active |
| Arvis ® | IN-22100 | FDA UDI | Class II | Active |
| 360cas | KIC-DND-0024 | FDA UDI | Class II | Active |
| 360cas | KIC-DND-0069 | FDA UDI | Class II | Active |
| Arvis ® | IN-22400 | FDA UDI | Class II | Active |
| 360cas | KIC-DND-0123 | FDA UDI | Class II | Active |
| Arvis ® | 14500 | FDA UDI | Class II | Active |
| Arvis ® | 10600 | FDA UDI | Class II | Active |
| Arvis ® | IN-22600 | FDA UDI | Class II | Active |
| Arvis ® | 19900 | FDA UDI | Class II | Active |
| Arvis ® | 21300 | FDA UDI | Class II | Active |
| KICo Probe | MO-PRB-0651-B | FDA UDI | Class I | Active |
| KICo AWL | MO-AWL-0650-C | FDA UDI | Class I | Active |
| 360cas | K223927 | FDA 510(k) | Class II | Active |
| 360KS Implant Positioning System | K163405 | FDA 510(k) | Class II | Active |
| 360cas | K213380 | FDA 510(k) | Class II | Active |
| ARVIS Surgical Navigation System | K243980 | FDA 510(k) | Class II | Active |
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