BowTie SI Fusion System
BowTie Implant stabilizes the sacroiliac joint while fusion occurs. The implant combines an interarticular component with an iliac screw and a transfix screw, with different sizes available…
BowTie Implant stabilizes the sacroiliac joint while fusion occurs. The implant combines an interarticular component with an iliac screw and a transfix screw, with different sizes available for patient anatomy.
The interarticular component is additively manufactured from Ti-6Al-4V ELI titanium alloy, while the screws are machined from the same alloy. Implant components are individually packaged and gamma sterilized.
Listed Item
BowTie Implant, Right, 45mm
Required Fixation
The system is indicated for sacroiliac joint fusion in conditions including joint disruptions and degenerative sacroiliitis. Both the iliac screw and transfix screw must be used when the implant is placed. Ancillary placement instruments are supplied nonsterile for sterilization by the user.
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 | Sail Fusion, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Complaint-file establishment |
| 510(k) | K232149 |
| Record published | 2024-05-24 |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-JFA-200085 | In distribution | |
| 90-JFA-200055 | In distribution | |
| 90-JFA-300025 | In distribution | |
| 90-JFA-105045 | In distribution | |
| 90-JFA-300005 | In distribution | |
| 90-JFA-200065 | In distribution | |
| 90-JFA-200060 | In distribution | |
| 90-JFA-105035 | In distribution | |
| 90-JFA-105040 | In distribution | |
| 90-JFA-200090 | In distribution | |
| 90-JFA-200075 | In distribution | |
| 90-JFA-105030 | In distribution | |
| 90-JFA-300020 | In distribution | |
| 90-JFA-200095 | In distribution | |
| 90-JFA-300015 | In distribution | |
| PKG-90-JFA-200045 | In distribution | |
| 90-JFA-300010 | In distribution | |
| 90-JFA-200080 | In distribution | |
| 90-JFA-100045 | In distribution | |
| 90-JFA-200105 | In distribution | |
| 90-JFA-100030 | In distribution | |
| 90-JFA-100050 | In distribution | |
| 90-JFA-100035 | In distribution | |
| 90-JFA-105050 | In distribution | |
| 90-JFA-100040 | In distribution | |
| 90-JFA-200070 | In distribution | |
| 90-JFA-200100 | In distribution | |
| PKG-90-JFA-200050 | 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 |
|---|---|
| K232149 | 2024-04-20 |
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.