Nexxt Matrixx® SI System
Nexxt Matrixx SI is a titanium implant system for sacroiliac joint fusion and specified pelvic fracture fixation. The family includes press-fit shafts and threaded implants for different…
Nexxt Matrixx SI is a titanium implant system for sacroiliac joint fusion and specified pelvic fracture fixation. The family includes press-fit shafts and threaded implants for different fixation approaches.
The additively manufactured range comprises Impaxx SI, Helixx SI Fully Threaded and Helixx SI Lag implants. Titanium alloy components are available in sizes selected for the patient’s anatomy.
Listed Item
HELIXX SI Fully Threaded Implant, Ø12x45mm
Implant Options
Helixx SI Lag implants can be combined with optional modular washers. The system can also augment sacroiliac stabilization during sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The listed family includes a fully threaded Helixx implant, with each configuration selected for its intended fixation role.
3manufacturers in China registered for this device type
106catalogue numbers in this listing
1510(k) clearance
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 | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K243838 |
| Record published | 2025-04-24 |
| Record revised | 2026-07-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 3.15 to 20.4 mm; length 30 to 508 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64-HE-1245-SP | Outer Diameter 12 mm | In distribution |
| 64-MP-1245-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1250-SP | Outer Diameter 12 mm | In distribution |
| I64-05-03 | Outer Diameter 3.15 mm | In distribution |
| 64-MP-1255-SP | Outer Diameter 12 mm | In distribution |
| I64-05-10 | Outer Diameter 14.45 mm | In distribution |
| 64-HE-1090-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1030-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1040-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1280-SP | Outer Diameter 12 mm | In distribution |
| I64-05-12 | Outer Diameter 16.75 mm | In distribution |
| I64-05-02 | Outer Diameter 3.15 mm | In distribution |
| 64-HE-1035-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1055-SP | Outer Diameter 10 mm | In distribution |
| C64-01-01 | In distribution | |
| 64-MP-1070-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1240-SP | Outer Diameter 12 mm | In distribution |
| 64-MP-1035-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1055-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1240-SP | Outer Diameter 12 mm | In distribution |
| I64-15-06 | In distribution | |
| I64-10-12 | Outer Diameter 12 mm | In distribution |
| I64-05-25 | In distribution | |
| 64-WA-12 | In distribution | |
| 64-MP-1240-SP | Outer Diameter 12 mm | In distribution |
| 64-MP-1235-SP | Outer Diameter 12 mm | In distribution |
| I64-15-08 | In distribution | |
| 64-MP-1045-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1275-SP | Outer Diameter 12 mm | In distribution |
| I64-05-26 | In distribution | |
| 64-HE-1050-SP | Outer Diameter 10 mm | In distribution |
| I64-20-03 | In distribution | |
| 64-LB-1065-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1060-SP | Outer Diameter 10 mm | In distribution |
| I64-10-10 | Outer Diameter 10 mm | In distribution |
| 64-MP-1040-SP | Outer Diameter 10 mm | In distribution |
| I64-20-01 | In distribution | |
| 64-MP-1080-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1290-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1045-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1250-SP | Outer Diameter 12 mm | In distribution |
| I64-05-01 | Outer Diameter 3.15 mm | In distribution |
| I64-15-07 | In distribution | |
| 64-HE-1285-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1060-SP | Outer Diameter 10 mm | In distribution |
| I64-05-13 | Outer Diameter 20.4 mm | In distribution |
| 64-HE-1040-SP | Outer Diameter 10 mm | In distribution |
| I64-05-05 | In distribution | |
| 64-HE-1250-SP | Outer Diameter 12 mm | In distribution |
| 64-MP-1270-SP | Outer Diameter 12 mm | In distribution |
| I64-15-04 | In distribution | |
| 64-HE-1085-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1050-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1075-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1055-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1230-SP | Outer Diameter 12 mm | In distribution |
| I64-05-04 | Outer Diameter 3.15 mm | In distribution |
| 64-LB-1245-SP | Outer Diameter 12 mm | In distribution |
| 64-HE-1070-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1085-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1080-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1060-SP | Outer Diameter 10 mm | In distribution |
| I64-15-01 | In distribution | |
| 64-MP-1280-SP | Outer Diameter 12 mm | In distribution |
| I64-08-07 | Outer Diameter 7 mm | In distribution |
| C64-02-01 | In distribution | |
| 64-LB-1270-SP | Outer Diameter 12 mm | In distribution |
| 64-HE-1075-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1070-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1065-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1290-SP | Outer Diameter 12 mm | In distribution |
| I64-05-11 | Outer Diameter 18 mm | In distribution |
| 64-WA-10 | In distribution | |
| 64-MP-1260-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1085-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1035-SP | Outer Diameter 10 mm | In distribution |
| I64-20-02 | In distribution | |
| 64-HE-1260-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1050-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1260-SP | Outer Diameter 12 mm | In distribution |
| I64-16-02 | In distribution | |
| 64-HE-1065-SP | Outer Diameter 10 mm | In distribution |
| I64-05-27 | In distribution | |
| 64-LB-1285-SP | Outer Diameter 12 mm | In distribution |
| 64-HE-1275-SP | Outer Diameter 12 mm | In distribution |
| 64-HE-1280-SP | Outer Diameter 12 mm | In distribution |
| I64-15-02 | In distribution | |
| 64-LB-1265-SP | Outer Diameter 12 mm | In distribution |
| 64-HE-1255-SP | Outer Diameter 12 mm | In distribution |
| I64-05-20 | In distribution | |
| 64-LB-1080-SP | Outer Diameter 10 mm | In distribution |
| 64-LB-1275-SP | Outer Diameter 12 mm | In distribution |
| I64-15-03 | In distribution | |
| 64-LB-1090-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1235-SP | Outer Diameter 12 mm | In distribution |
| 64-HE-1270-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1235-SP | Outer Diameter 12 mm | In distribution |
| I64-15-05 | In distribution | |
| 64-HE-1045-SP | Outer Diameter 10 mm | In distribution |
| 64-MP-1265-SP | Outer Diameter 12 mm | In distribution |
| I64-05-28 | In distribution | |
| I64-08-09 | Outer Diameter 9 mm | In distribution |
| 64-MP-1075-SP | Outer Diameter 10 mm | In distribution |
| 64-HE-1265-SP | Outer Diameter 12 mm | In distribution |
| 64-MP-1285-SP | Outer Diameter 12 mm | In distribution |
| 64-LB-1255-SP | Outer Diameter 12 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 |
|---|---|
| K243838 | 2025-03-14 |
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.