OptumSI Implant System
OptumSI is an implant system for stabilizing and fusing the sacroiliac joint. The cannulated implant has a diamond-shaped body and porous surface designed to limit joint motion. An…
OptumSI is an implant system for stabilizing and fusing the sacroiliac joint. The cannulated implant has a diamond-shaped body and porous surface designed to limit joint motion. An interference fit provides fixation between the implant and surrounding bone.
The implant is Ti-6Al-4V ELI titanium alloy. Available lengths vary by configuration, and each implant is supplied sterile in an individual package. The filed 11.5 mm by 45 mm implant is one option in the family.
Listed Item
Sacroiliac Joint Fusion Implant, 11.5mm x 45mm
Implant Delivery
A reprocessable instrument set assists access and delivery. The system uses a transverse approach from the ilium toward the sacrum, along a lateral or lateral-to-medial trajectory. Its intended uses include sacroiliac joint disruption or degeneration, supplemental sacropelvic stabilization and fractures involving the joint.
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 | SI Solutions, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K251365 |
| Record published | 2025-12-16 |
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, expiry date |
| Sizes | Length 30 to 70 mm; width 11.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-00042 | In distribution | |
| 12-00026 | In distribution | |
| 12-00040 | In distribution | |
| 12-00041 | In distribution | |
| 11-11545 | Length 45 mm | In distribution |
| 11-11535 | Length 35 mm | In distribution |
| 12-00005 | In distribution | |
| 12-00027 | In distribution | |
| 11-11555 | Length 55 mm | In distribution |
| 11-11565 | Length 65 mm | In distribution |
| 12-00037 | In distribution | |
| 11-11530 | Length 30 mm | In distribution |
| 12-00002 | In distribution | |
| 12-00011 | In distribution | |
| 12-00001 | In distribution | |
| 12-00021 | In distribution | |
| 11-11540 | Length 40 mm | In distribution |
| 12-00035 | In distribution | |
| 12-00030 | In distribution | |
| 11-11550 | Length 50 mm | In distribution |
| 12-00004 | In distribution | |
| 11-11560 | Length 60 mm | In distribution |
| 12-00017 | In distribution | |
| 12-00010 | In distribution | |
| 12-00003 | In distribution | |
| 11-11570 | Length 70 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 |
|---|---|
| K251365 | 2025-11-20 |
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.