Siconus™ SI Joint Fixation System
Siconus is a cannulated sacroiliac-joint fixation device with a partially threaded design. Its distal buttress-style thread secures it in cancellous bone, while the conical proximal head…
Siconus is a cannulated sacroiliac-joint fixation device with a partially threaded design. Its distal buttress-style thread secures it in cancellous bone, while the conical proximal head applies compression across the joint.
A tapered thread on the head advances into cortical bone while helping maintain compression. A smooth shaft connects the head and distal threaded portion.
Listed Item
Ø11mm Bone Screw, Cannulated, 35mm
Fusion Configuration
The larger device version has an axial slot in the shaft for packing bone graft. The system is intended for sacroiliac fusion in conditions including degenerative sacroiliitis and sacroiliac-joint disruption, with the screw geometry providing fixation and compression across 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 | Camber Spine Technologies, 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162121 |
| Record published | 2017-02-07 |
| Record revised | 2020-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 30 to 70 mm; outer diameter 7 to 11 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCL-11-035 | Length 35 mm | In distribution |
| SCL-11-045 | Length 45 mm | In distribution |
| SCL-07-040 | Outer Diameter 7 mm | In distribution |
| SCL-11-050 | Outer Diameter 11 mm | In distribution |
| SCL-11-060 | Outer Diameter 11 mm | In distribution |
| SCL-11-065 | Length 65 mm | In distribution |
| SCL-07-070 | Outer Diameter 7 mm | In distribution |
| SCL-07-065 | Length 65 mm | In distribution |
| SCL-07-035 | Length 35 mm | In distribution |
| SCL-11-055 | Length 55 mm | In distribution |
| SCL-07-045 | Length 45 mm | In distribution |
| SCL-07-060 | Outer Diameter 7 mm | In distribution |
| SCL-07-030 | Length 30 mm | In distribution |
| SCL-07-055 | Length 55 mm | In distribution |
| SCL-11-040 | Outer Diameter 11 mm | In distribution |
| SCL-07-050 | Outer Diameter 7 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 |
|---|---|
| K233972 | 2024-02-27 |
| K203503 | 2022-09-02 |
| K162121 | 2017-01-18 |
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.