ARx SAI
ARx SAI is a titanium alloy implant system for sacroiliac joint fusion and sacropelvic fixation. Its screw assemblies combine a bone screw, head and taper lock assembled during manufacture.…
ARx SAI is a titanium alloy implant system for sacroiliac joint fusion and sacropelvic fixation. Its screw assemblies combine a bone screw, head and taper lock assembled during manufacture. Different lengths and diameters are available, with instruments for open or minimally invasive placement.
The system can follow a sacral alar iliac trajectory for sacroiliac fusion. It can also provide foundational stabilization in sacral alar iliac or iliac trajectories when connected to pedicle screw fixation, and can be placed into the S1 pedicle.
Connection and Indications
Connections are designed for ARx rods of 5.5 or 6.0 mm diameter in titanium alloy or cobalt-chromium alloy. Sacroiliac indications include dysfunction, degenerative sacroiliitis and fractures involving the joint, plus augmentation during lumbar or thoracolumbar sacropelvic fixation in skeletally mature patients. Pregnancy-related symptoms must have persisted postpartum for more than six months.
3manufacturers in China registered for this device type
224catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Life Spine, 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) | K241464 |
| Record published | 2026-01-23 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CA9115-085-5 | In distribution | |
| 17-135105-09 | In distribution | |
| CA9125-080-5 | In distribution | |
| 17-12570-09 | In distribution | |
| CA9125-075-5 | In distribution | |
| CA9105-125-5 | In distribution | |
| CA9125-055-5 | In distribution | |
| CA9115-125-5 | In distribution | |
| CA9115-080-5 | In distribution | |
| 17-135100-19 | In distribution | |
| 17-115115-19 | In distribution | |
| CA9105-050-5 | In distribution | |
| 17-11595-19 | In distribution | |
| CA9145-050-5 | In distribution | |
| CA985-050-5 | In distribution | |
| 17-135100-09 | In distribution | |
| 17-12550-09 | In distribution | |
| 17-135120-09 | In distribution | |
| CA9145-110-5 | In distribution | |
| 17-11580-09 | In distribution | |
| CA9135-125-5 | In distribution | |
| CA9125-025-5 | In distribution | |
| CA9105-110-5 | In distribution | |
| 17-11525-09 | In distribution | |
| 17-12590-19 | In distribution | |
| 17-125110-09 | In distribution | |
| 17-135110-19 | In distribution | |
| 17-10580-19 | In distribution | |
| CA9115-120-5 | In distribution | |
| CA9135-065-5 | In distribution | |
| 17-12540-19 | In distribution | |
| 17-11565-09 | In distribution | |
| 17-11545-09 | In distribution | |
| 17-12555-19 | In distribution | |
| CA985-035-5 | In distribution | |
| CA9145-115-5 | In distribution | |
| CA9105-115-5 | In distribution | |
| 17-12530-09 | In distribution | |
| 17-12585-09 | In distribution | |
| CA9125-085-5 | In distribution | |
| CA9135-070-5 | In distribution | |
| CA9105-080-5 | In distribution | |
| 17-11590-09 | In distribution | |
| CA9125-125-5 | In distribution | |
| CA9145-105-5 | In distribution | |
| 17-11570-09 | In distribution | |
| CA9105-070-5 | In distribution | |
| CA985-065-5 | In distribution | |
| 17-12525-09 | In distribution | |
| CA985-100-5 | In distribution | |
| 17-115120-09 | In distribution | |
| CA9135-050-5 | In distribution | |
| 17-10585-19 | In distribution | |
| CA9125-030-5 | In distribution | |
| 17-125115-19 | In distribution | |
| CA9105-105-5 | In distribution | |
| CA9115-095-5 | In distribution | |
| 17-135110-09 | In distribution | |
| CA9115-060-5 | In distribution | |
| 17-125110-19 | In distribution | |
| 17-11545-19 | In distribution | |
| 17-12595-09 | In distribution | |
| NC995-120-5 | In distribution | |
| CA985-045-5 | In distribution | |
| CA985-080-5 | In distribution | |
| 17-115100-09 | In distribution | |
| CA9125-115-5 | In distribution | |
| CA9145-035-5 | In distribution | |
| CA9135-110-5 | In distribution | |
| CA9105-095-5 | In distribution | |
| 17-10595-19 | In distribution | |
| 17-10590-09 | In distribution | |
| CA985-055-5 | In distribution | |
| CA9135-080-5 | In distribution | |
| 17-11540-09 | In distribution | |
| 17-11575-09 | In distribution | |
| CA9115-045-5 | In distribution | |
| CA9145-065-5 | In distribution | |
| CA9135-115-5 | In distribution | |
| CA9115-090-5 | In distribution | |
| 17-10590-19 | In distribution | |
| 17-12565-09 | In distribution | |
| CA9135-090-5 | In distribution | |
| CA985-085-5 | In distribution | |
| CA9105-040-5 | In distribution | |
| CA9125-095-5 | In distribution | |
| 17-11550-09 | In distribution | |
| CA9115-115-5 | In distribution | |
| CA9115-110-5 | In distribution | |
| 17-11570-09 | In distribution | |
| CA9125-110-5 | In distribution | |
| CA9125-050-5 | In distribution | |
| 17-12550-19 | In distribution | |
| 17-12580-19 | In distribution | |
| CA9145-070-5 | In distribution | |
| CA9135-040-5 | In distribution | |
| CA9105-060-5 | In distribution | |
| CA9145-125-5 | In distribution | |
| 17-135115-09 | In distribution | |
| 17-11540-19 | In distribution | |
| CA9145-040-5 | In distribution | |
| CA9115-055-5 | In distribution | |
| 17-135120-19 | In distribution | |
| CA9105-065-5 | In distribution | |
| CA9105-035-5 | In distribution | |
| CA985-115-5 | In distribution | |
| 17-11595-09 | In distribution | |
| CA9135-120-5 | In distribution | |
| 17-12575-19 | In distribution | |
| 17-125125-19 | In distribution | |
| CA9125-040-5 | In distribution | |
| CA9115-035-5 | In distribution | |
| NC995-125-5 | In distribution | |
| 17-12595-19 | In distribution | |
| CA9115-105-5 | In distribution | |
| 17-125125-09 | In distribution | |
| CA985-060-5 | In distribution | |
| CA9145-055-5 | In distribution | |
| 17-115105-19 | In distribution | |
| 17-10595-09 | In distribution | |
| CA9115-070-5 | In distribution | |
| 17-12545-09 | In distribution | |
| CA9105-030-5 | In distribution | |
| CA9105-120-5 | In distribution | |
| 17-12565-19 | In distribution | |
| CA9135-055-5 | In distribution | |
| CA9145-075-5 | In distribution | |
| 17-115115-09 | In distribution | |
| CA9145-120-5 | In distribution | |
| CA985-075-5 | In distribution | |
| CA985-070-5 | In distribution | |
| CA9115-075-5 | In distribution | |
| 17-125105-09 | In distribution | |
| 17-11585-19 | In distribution | |
| CA9145-080-5 | In distribution | |
| 17-125115-09 | In distribution | |
| 17-115100-19 | In distribution | |
| CA9135-035-5 | In distribution | |
| CA9115-040-5 | In distribution | |
| 17-12580-09 | In distribution | |
| 17-11565-19 | In distribution | |
| 17-135105-19 | In distribution | |
| CA9135-105-5 | In distribution | |
| CA985-025-5 | In distribution | |
| 17-135125-09 | In distribution | |
| 17-115120-19 | In distribution | |
| CA985-095-5 | In distribution | |
| CA9105-100-5 | In distribution | |
| 17-11530-09 | In distribution | |
| CA9105-025-5 | In distribution | |
| CA985-090-5 | In distribution | |
| CA9105-045-5 | In distribution | |
| CA9125-070-5 | In distribution | |
| 17-125120-19 | In distribution | |
| CA9105-055-5 | In distribution | |
| CA9125-105-5 | In distribution | |
| 17-115125-19 | In distribution | |
| CA9145-045-5 | In distribution | |
| 17-12535-09 | In distribution | |
| 17-12560-09 | In distribution | |
| 17-11535-19 | In distribution | |
| CA9115-050-5 | In distribution | |
| 17-11555-19 | In distribution | |
| 17-11580-19 | In distribution | |
| CA9125-120-5 | In distribution | |
| CA985-040-5 | In distribution | |
| 17-12585-19 | In distribution | |
| 17-12590-09 | In distribution | |
| CA9145-095-5 | In distribution | |
| 17-11590-19 | In distribution | |
| 17-11585-09 | In distribution | |
| CA9135-045-5 | In distribution | |
| CA9125-045-5 | In distribution | |
| 17-11550-19 | In distribution | |
| 17-125100-09 | In distribution | |
| 17-11560-09 | In distribution | |
| 17-12530-19 | In distribution | |
| 17-11575-19 | In distribution | |
| 17-125105-19 | In distribution | |
| 17-11525-09 | In distribution | |
| 17-11530-19 | In distribution | |
| CA9145-060-5 | In distribution | |
| CA9125-065-5 | In distribution | |
| CA9135-085-5 | In distribution | |
| 17-12535-19 | In distribution | |
| CA9115-030-5 | In distribution | |
| 17-12540-09 | In distribution | |
| 17-135115-19 | In distribution | |
| 17-12575-09 | In distribution | |
| CA9105-090-5 | In distribution | |
| 17-12525-19 | In distribution | |
| CA985-030-5 | In distribution | |
| 17-11555-09 | In distribution | |
| CA9115-025-5 | In distribution | |
| CA9145-090-5 | In distribution | |
| CA9135-095-5 | In distribution | |
| 17-12570-19 | In distribution | |
| CA9135-030-5 | In distribution | |
| 17-115110-19 | In distribution | |
| 17-125120-09 | In distribution | |
| CA9135-075-5 | In distribution | |
| 17-12560-19 | In distribution | |
| CA9115-065-5 | In distribution | |
| CA9145-030-5 | In distribution | |
| 17-10585-09 | In distribution | |
| 17-115110-09 | In distribution | |
| 17-11535-09 | In distribution | |
| CA9125-090-5 | In distribution | |
| CA9145-025-5 | In distribution | |
| CA9145-085-5 | In distribution | |
| 17-12545-19 | In distribution | |
| 17-11560-19 | In distribution | |
| CA9125-035-5 | In distribution | |
| CA9135-060-5 | In distribution | |
| CA9125-060-5 | In distribution | |
| 17-12555-09 | In distribution | |
| 17-115105-09 | In distribution | |
| 17-115125-09 | In distribution | |
| CA985-110-5 | In distribution | |
| CA985-105-5 | In distribution | |
| CA9105-075-5 | In distribution | |
| CA9105-085-5 | In distribution | |
| CA9135-025-5 | In distribution | |
| 17-125100-19 | 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 |
| 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 |
| Dynamis™ Implant System | Promethean Restorative Inc. | 120 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241464 | 2024-07-29 |
| K212903 | 2021-12-15 |
| K201538 | 2020-09-18 |
| K180749 | 2018-06-15 |
| K141246 | 2015-02-22 |
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.