Arvis ®
ARVIS Global Hip and Knee 2.0 Navigation System
5manufacturers in China registered for this device type
174catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
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) | K243980 |
| Record published | 2025-11-17 |
| Record revised | 2025-03-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IN-29030 | In distribution | |
| IN-18500 | In distribution | |
| IN-10400 | In distribution | |
| IN-17500 | In distribution | |
| IN-18900 | In distribution | |
| 16300 | In distribution | |
| IN-28010 | In distribution | |
| IN-16400 | In distribution | |
| IN-29100 | In distribution | |
| IN-17600 | In distribution | |
| 20100 | In distribution | |
| 10100 | In distribution | |
| 11600 | In distribution | |
| IN-20300 | In distribution | |
| IN-28150 | In distribution | |
| 14700 | In distribution | |
| IN-29005 | In distribution | |
| IN-14100 | In distribution | |
| 11500 | In distribution | |
| IN-14700 | In distribution | |
| IN-10200 | In distribution | |
| IN-16100 | In distribution | |
| 18500 | In distribution | |
| IN-29102 | In distribution | |
| 15300 | In distribution | |
| 20400 | In distribution | |
| IN-22300 | In distribution | |
| IN-23000 | In distribution | |
| IN-28130 | In distribution | |
| 10900 | In distribution | |
| 11800 | In distribution | |
| IN-11000 | In distribution | |
| IN-21300 | In distribution | |
| IN-13200 | In distribution | |
| 14200 | In distribution | |
| 23000 | In distribution | |
| IN-29003 | In distribution | |
| IN-15900 | In distribution | |
| IN-10600 | In distribution | |
| IN-29007 | In distribution | |
| 12000 | In distribution | |
| IN-13800 | In distribution | |
| IN-20000 | In distribution | |
| IN-21100 | In distribution | |
| 13000 | In distribution | |
| 16100 | In distribution | |
| 21100 | In distribution | |
| IN-17100 | In distribution | |
| IN-12800 | In distribution | |
| 12100 | In distribution | |
| IN-29001 | In distribution | |
| IN-17300 | In distribution | |
| 10800 | In distribution | |
| 3.3.1 | In distribution | |
| IN-15600 | In distribution | |
| 15400 | In distribution | |
| 15700 | In distribution | |
| IN-28120 | In distribution | |
| 22100 | In distribution | |
| 19100 | In distribution | |
| IN-15200 | In distribution | |
| IN-22100 | In distribution | |
| 21200 | In distribution | |
| 19200 | In distribution | |
| IN-14200 | In distribution | |
| 21300 | In distribution | |
| 11000 | In distribution | |
| 16500 | In distribution | |
| 18900 | In distribution | |
| IN-12500 | In distribution | |
| IN-16200 | In distribution | |
| 18600 | In distribution | |
| 12200 | In distribution | |
| 12700 | In distribution | |
| 17300 | In distribution | |
| IN-29200 | In distribution | |
| 20000 | In distribution | |
| 16400 | In distribution | |
| 17700 | In distribution | |
| 14500 | In distribution | |
| 15800 | In distribution | |
| 14300 | In distribution | |
| IN-21900 | In distribution | |
| IN-28050 | In distribution | |
| 20300 | In distribution | |
| IN-28020 | In distribution | |
| 10700 | In distribution | |
| 13200 | In distribution | |
| 10600 | In distribution | |
| IN-15202 | In distribution | |
| IN-19900 | In distribution | |
| IN-12700 | In distribution | |
| 10400 | In distribution | |
| IN-21904 | In distribution | |
| 16600 | In distribution | |
| 17100 | In distribution | |
| IN-27200 | In distribution | |
| 15900 | In distribution | |
| 17900 | In distribution | |
| IN-18300 | In distribution | |
| 14100 | In distribution | |
| IN-29101 | In distribution | |
| IN-21902 | In distribution | |
| 11900 | In distribution | |
| 15600 | In distribution | |
| IN-10800 | In distribution | |
| IN-17700 | In distribution | |
| IN-20100 | In distribution | |
| IN-21700 | In distribution | |
| 11200 | In distribution | |
| 17500 | In distribution | |
| 13900 | In distribution | |
| 18000 | In distribution | |
| 12800 | In distribution | |
| 15200 | In distribution | |
| IN-20200 | In distribution | |
| IN-18600 | In distribution | |
| 22200 | In distribution | |
| 16700 | In distribution | |
| 13800 | In distribution | |
| 15500 | In distribution | |
| 21700 | In distribution | |
| 12300 | In distribution | |
| 11400 | In distribution | |
| 22300 | In distribution | |
| 20200 | In distribution | |
| IN-50010 | In distribution | |
| 14600 | In distribution | |
| 11100 | In distribution | |
| IN-28100 | In distribution | |
| IN-21200 | In distribution | |
| IN-29002 | In distribution | |
| 17600 | In distribution | |
| IN-12400 | In distribution | |
| 2.5.1 | In distribution | |
| 11700 | In distribution | |
| IN-17200 | In distribution | |
| 12500 | In distribution | |
| 18300 | In distribution | |
| IN-29008 | In distribution | |
| 16200 | In distribution | |
| 11300 | In distribution | |
| IN-29019 | In distribution | |
| 19900 | In distribution | |
| IN-28160 | In distribution | |
| IN-29000 | In distribution | |
| 21000 | In distribution | |
| 12400 | In distribution | |
| IN-28070 | In distribution | |
| 10200 | In distribution | |
| 10500 | In distribution | |
| 27200 | In distribution | |
| IN-13000 | In distribution | |
| 17200 | In distribution | |
| IN-20400 | In distribution | |
| IN-24000 | In distribution | |
| IN-10500 | In distribution | |
| IN-15800 | In distribution | |
| IN-29033 | In distribution | |
| IN-29018 | In distribution | |
| IN-15700 | In distribution | |
| IN-15201 | In distribution | |
| IN-22200 | In distribution | |
| 10300 | In distribution | |
| IN-29026 | In distribution | |
| IN-29006 | In distribution | |
| IN-50000 | In distribution | |
| IN-27300 | In distribution | |
| 17000 | In distribution | |
| IN-16300 | In distribution | |
| IN-19100 | In distribution | |
| IN-21000 | In distribution | |
| 24000 | In distribution | |
| IN-13900 | 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 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
| Orthopedic Stereotaxic Instrument | Mako Surgical Corp. | 124 |
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 Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Kico Knee Innovation Company | UDI-DI | 2026-07-13 | Class II | Device Design | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing | 78 |
| Kico Knee Innovation Company | UDI-DI | 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 |
| Kico Knee Innovation Company | UDI-DI | 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 |
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.