Blue Topaz Sacroiliac Screw System
Blue Topaz Sacroiliac Screw System uses cannulated, fully threaded screws to facilitate sacroiliac joint fusion. It is intended for conditions including sacroiliac joint disruption and…
Blue Topaz Sacroiliac Screw System uses cannulated, fully threaded screws to facilitate sacroiliac joint fusion. It is intended for conditions including sacroiliac joint disruption and degenerative sacroiliitis.
The implants are made from Ti-6Al-4V ELI titanium alloy. Different screw sizes and lengths accommodate patient anatomy, and optional washers are available for each screw diameter.
Listed Item
Sacroiliac Screw, 12.5x50mm, Blue Topaz
Fixation Configuration
The screw and washer options let the surgeon select a construct suited to the joint and surrounding anatomy. The system’s role is fixation for fusion of the sacroiliac joint, with the fully threaded screw forming the principal implant component.
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 | Osseus Fusion Systems LLC, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213590 |
| Record published | 2023-06-09 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3000-12550 | In distribution | |
| 3000-11580 | In distribution | |
| 3000-12545 | In distribution | |
| 3000-08575 | In distribution | |
| 3000-12530 | In distribution | |
| 3000-08560 | In distribution | |
| 3000-09535 | In distribution | |
| 3000-12565 | In distribution | |
| 3000-12560 | In distribution | |
| 3000-09540 | In distribution | |
| 3000-11570 | In distribution | |
| 3000-11540 | In distribution | |
| 3000-10560 | In distribution | |
| 3000-08555 | In distribution | |
| 3000-12575 | In distribution | |
| 3000-09565 | In distribution | |
| 3000-12535 | In distribution | |
| 3000-10545 | In distribution | |
| 3000-08545 | In distribution | |
| 3000-10555 | In distribution | |
| 3000-08550 | In distribution | |
| 3000-12555 | In distribution | |
| 3000-09570 | In distribution | |
| 3000-10540 | In distribution | |
| 3000-11560 | In distribution | |
| 3000-12580 | In distribution | |
| 3000-1000 | In distribution | |
| 3000-11565 | In distribution | |
| 3000-08580 | In distribution | |
| 3000-10565 | In distribution | |
| 3000-10580 | In distribution | |
| 3000-09560 | In distribution | |
| 3000-12570 | In distribution | |
| 3000-09550 | In distribution | |
| 3000-11555 | In distribution | |
| 3000-10530 | In distribution | |
| 3000-10570 | In distribution | |
| 3000-08565 | In distribution | |
| 3000-12540 | In distribution | |
| 3000-11545 | In distribution | |
| 3000-09580 | In distribution | |
| 3000-1200 | In distribution | |
| 3000-09530 | In distribution | |
| 3000-11530 | In distribution | |
| 3000-11535 | In distribution | |
| 3000-09545 | In distribution | |
| 3000-09555 | In distribution | |
| 3000-09575 | In distribution | |
| 3000-08540 | In distribution | |
| 3000-10535 | In distribution | |
| 3000-08535 | In distribution | |
| 3000-08530 | In distribution | |
| 3000-08570 | In distribution | |
| 3000-10575 | In distribution | |
| 3000-11575 | In distribution | |
| 3000-11550 | In distribution | |
| 3000-10550 | 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 |
|---|---|
| K213590 | 2022-03-01 |
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.