SiJoin T3 Titanium
The SiJoin T3 Titanium implant supports sacroiliac joint fusion for conditions including joint disruption and degenerative sacroiliitis. It crosses the joint to provide mechanical support…
The SiJoin T3 Titanium implant supports sacroiliac joint fusion for conditions including joint disruption and degenerative sacroiliitis. It crosses the joint to provide mechanical support while biological fusion occurs. Two SiJoin T3 implants must be used in the same sacroiliac joint.
The device consists of an implant body with perpendicular fins. These fins provide stability as part of the joint-spanning implant design. The implant is made from titanium alloy conforming to ASTM F3001.
Listed Item
SiJoin T3 Titanium 16x20x5 Implant The VGI Medical, LLC SiJoin®T3 Implant consists of a series of titanium alloy (per ASTM F3001) implants that are designed to provide mechanical support by transfixing the sacroiliac joint while biologic fusion occurs. The device consists of the implant body and perpendicular fins to provide stability while fusion occurs. The devices are available in five sizes to accommodate varied patient’s anatomy.
Size Options
SiJoin T3 implants are offered in five sizes to accommodate different patient anatomy.
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 | VGI medical, LLC, 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) | K213815 |
| Record published | 2023-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Sizes | Width 16 to 22 mm; length 20 to 40 mm; height 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VG-SJ-T3-22220 | Width 22 mm | In distribution |
| VG-SJ-T3-22240 | Width 22 mm | In distribution |
| VG-SJ-T3-21620 | Width 16 mm | In distribution |
| VG-SJ-T3-21630 | Width 16 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 |
|---|---|
| K213815 | 2023-03-29 |
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.