Evol®si Joint Fusion System
EVOL-SI is a sacroiliac-joint fusion system using titanium-alloy screws and optional washers. The screws cross the joint to anchor the sacrum to the pelvis. Each screw has a hydroxyapatite…
EVOL-SI is a sacroiliac-joint fusion system using titanium-alloy screws and optional washers. The screws cross the joint to anchor the sacrum to the pelvis.
Each screw has a hydroxyapatite surface treatment approximately 20 nanometres thick. The underlying screw material is Ti-6Al-4V ELI titanium alloy.
Listed Item
EVOL®SI Stackable Steinmann Pin, 3.2 Blunt End
Implants and Placement
The system includes instruments for placing the screws in the body. It is intended for sacroiliac-joint fusion in conditions including joint disruption and degenerative sacroiliitis. The implants are single-use components, distinct from the associated guide and placement instruments.
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 | Cutting Edge Spine, 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) | K190025 |
| Record published | 2020-08-25 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at room temperature |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5006-050T-32 | In distribution | |
| 5006-025T-32 | In distribution | |
| 5006-055T | In distribution | |
| 5006-060T | In distribution | |
| 5005-040T | In distribution | |
| 5006-040T | In distribution | |
| CES-311 | In distribution | |
| 5004-060T | In distribution | |
| 5002-040T | In distribution | |
| 5005-045T-32 | In distribution | |
| 5004-025T | In distribution | |
| 5002-055T | In distribution | |
| 5005-030T-32 | In distribution | |
| 5006-040T-32 | In distribution | |
| 5005-060T-32 | In distribution | |
| 5004-055T | In distribution | |
| 5006-055T-32 | In distribution | |
| 5005-WT | In distribution | |
| 5004-WT | In distribution | |
| 5006-WT | In distribution | |
| 5006-035T-32 | In distribution | |
| 5005-035T | In distribution | |
| 5006-030T-32 | In distribution | |
| 5006-045T-32 | In distribution | |
| 5005-025T | In distribution | |
| 5002-WT | In distribution | |
| 5002-060T | In distribution | |
| 5004-045T | In distribution | |
| 5005-045T | In distribution | |
| CES-318 | In distribution | |
| 5002-035T | In distribution | |
| 5006-050T | In distribution | |
| 5002-050T | In distribution | |
| 5005-060T | In distribution | |
| 5006-045T | In distribution | |
| 5006-030T | In distribution | |
| 5006-025T | In distribution | |
| 5004-030T | In distribution | |
| 5004-050T | In distribution | |
| 5006-060T-32 | In distribution | |
| 5004-035T | In distribution | |
| 5005-040T-32 | In distribution | |
| 5002-045T | In distribution | |
| 5005-055T-32 | In distribution | |
| 5005-025T-32 | In distribution | |
| 5005-030T | In distribution | |
| 5005-050T | In distribution | |
| 5004-040T | In distribution | |
| 5005-055T | In distribution | |
| 5006-035T | In distribution | |
| 5005-050T-32 | 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 |
|---|---|
| K230689 | 2023-04-05 |
| K214123 | 2022-06-24 |
| K190025 | 2019-08-12 |
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.