10x40mm SIJ Implant
The Catamaran SIJ implant is used for sacroiliac joint fusion in patients with joint disruptions or degenerative sacroiliitis. It is a titanium implant with two hollow barrels joined by a…
The Catamaran SIJ implant is used for sacroiliac joint fusion in patients with joint disruptions or degenerative sacroiliitis. It is a titanium implant with two hollow barrels joined by a bridge, providing a structure that crosses the joint during fixation.
Autologous bone graft is placed in the implant barrel during the procedure. The 10 mm by 40 mm configuration is one of the implant sizes available to accommodate patient anatomy. Placement uses the associated access, drilling and delivery instruments.
Preparation and Use
The implant is intended for a single use. It is supplied clean and nonsterile and requires routine steam sterilization before implantation.
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 | Tenon Medical, Inc., United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180818 |
| Record published | 2019-05-23 |
| Record revised | 2022-11-28 (version 5) |
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, expiry date, serial number |
| Distribution end date | 2021-12-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAT-04 | Withdrawn |
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 |
|---|---|
| K260477 | 2026-04-08 |
| K250403 | 2025-03-21 |
| K231944 | 2023-08-24 |
| K180818 | 2018-06-13 |
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.