Rialto™ SI Fusion System
Rialto SI Fusion System uses cannulated titanium alloy implants to stabilize the sacroiliac joint during fusion. The described implants are 12 mm in diameter and 40 to 60 mm long. Autograft…
Rialto SI Fusion System uses cannulated titanium alloy implants to stabilize the sacroiliac joint during fusion. The described implants are 12 mm in diameter and 40 to 60 mm long. Autograft or allograft may be placed in conjunction with the implants.
The system is intended for sacroiliac joint disruption and degenerative sacroiliitis. Implantation can use a minimally invasive approach with fluoroscopy or navigated instruments. The threaded 12 by 45 mm implant is one size within the described implant range.
Listed Item
Device 74200001245 Threaded 12X45
Instrument Compatibility
Dedicated reusable taps, drills and drivers are separate stainless-steel preparation instruments. They may connect to the IPC Powerease handpiece or compatible manual quick-connect handles. Navigated instrument versions are designed for the StealthStation system, distinguishing their guidance role from the implanted titanium devices.
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K161210 |
| Record published | 2025-05-08 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 8.6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 74200001245 | In distribution | |
| 74200001260 | 12mm x 60mm | In distribution |
| 9000245 | 12mm x 45mm | In distribution |
| NAV7426002 | In distribution | |
| 9000240 | 12mm x 40mm | In distribution |
| 9000260 | 12mm x 60mm | In distribution |
| 9000250 | 12mm x 50mm | In distribution |
| 9000255 | 12mm x 55mm | In distribution |
| 74200001255 | In distribution | |
| 7426003 | 12mm | In distribution |
| 7426002 | Outer Diameter 8.6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SI-LOK | Globus Medical, Inc. | 666 |
| Sacroiliac Joint Fusion System | Genesys Orthopedics Systems, LLC | 356 |
| SIros-X | Genesys Orthopedics Systems, LLC | 353 |
| PathLoc- SI Joint Fusion System | L&K Biomed Co., Ltd. | 229 |
| ARx SAI | Life Spine | 224 |
| Unity | Diomedical Co., Ltd. | 198 |
| SImmetry SI Joint Fusion System | Tenon Medical, Inc. | 173 |
| M.u.s.t. Sacral Iliac Screw and Pelvic Trauma System | Medacta International SA | 170 |
| Integrity-SI Fusion System | Lincotek Medical, LLC | 160 |
| Zespin SI Joint Fusion System | Aegis Spine | 150 |
| M.u.s.t. Sacral Iliac Screw System | Medacta International SA | 142 |
| Simmetry | Sivantage | 123 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161210 | 2016-08-12 |
| K110472 | 2012-05-29 |
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.