360CAS
360CAS is an orthopedic navigation system with knee and hip modules. The filing describes optical tracking to map patient morphology, navigate surgical instruments and implants, and assess…
360CAS is an orthopedic navigation system with knee and hip modules. The filing describes optical tracking to map patient morphology, navigate surgical instruments and implants, and assess joint status during surgery.
The system includes navigation software, surgical instruments, spatial tracking components and a navigation cart. Its stated uses cover computer-assisted knee and hip procedures.
Listed Item
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.
Navigation Workflow
The source describes separate 360CAS Knee and 360CAS Hip modules. The hip indication includes total hip arthroplasty using either posterior or anterior approaches.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Kico Knee Innovation Company, Australia |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K223927 |
| Record published | 2023-10-20 |
| Record revised | 2025-03-21 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIC-DND-0110 | In distribution | |
| KIC-SET-0028 | In distribution | |
| KIC-DND-0003 | In distribution | |
| 3.1.1 | In distribution | |
| 2.1.0 | In distribution | |
| KIC-DND-0105 | In distribution | |
| 3.2.0 | In distribution | |
| KIC-DND-0026 | In distribution | |
| KIC-DND-0103 | In distribution | |
| KIC-DND-0010 | In distribution | |
| KIC-DND-0024 | In distribution | |
| KIC-DND-0100 | In distribution | |
| KIC-DND-0126 | In distribution | |
| KIC-SET-0029 | In distribution | |
| KIC-DND-0108 | In distribution | |
| KIC-DND-0076 | In distribution | |
| KIC-DND-0107 | In distribution | |
| KIC-DND-0145 | In distribution | |
| KIC-SET-0005 | In distribution | |
| KIC-DND-0147 | In distribution | |
| KIC-DND-0013 | In distribution | |
| KIC-DND-0102 | In distribution | |
| KIC-DND-0002 | In distribution | |
| KIC-DND-0106 | In distribution | |
| 3.1.0 | In distribution | |
| 2.2.0 | In distribution | |
| KIC-SET-0023 | In distribution | |
| KIC-DND-0235 | In distribution | |
| KIC-DND-0125 | In distribution | |
| KIC-DND-0104 | In distribution | |
| KIC-DND-0028 | In distribution | |
| KIC-DND-0109 | In distribution | |
| KIC-DND-0123 | In distribution | |
| KIC-DND-0142 | In distribution | |
| KIC-DND-0039 | In distribution | |
| KIC-DND-0075 | In distribution | |
| KIC-DND-0113 | In distribution | |
| KIC-DND-0004 | In distribution | |
| KIC-DND-0068 | In distribution | |
| KIC-DND-0069 | In distribution | |
| KIC-SET-0011 | In distribution | |
| KIC-DND-0120 | In distribution | |
| KIC-DND-0025 | In distribution | |
| KIC-SET-0022 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242009 | 2024-08-08 |
| K223927 | 2023-01-27 |
| K213380 | 2022-01-11 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-23 | Class II | Device Design | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. | 124 kits |
| 2026-04-23 | Class II | Device Design | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. | 69 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.