PathLoc- SI Joint Fusion System
PathLoc SI Joint Fusion System is a family of titanium alloy bone screws used for sacroiliac joint fusion. The implants provide fixation for conditions including disruption of the joint and…
PathLoc SI Joint Fusion System is a family of titanium alloy bone screws used for sacroiliac joint fusion. The implants provide fixation for conditions including disruption of the joint and degenerative sacroiliitis.
The screw range includes different diameters, lengths and thread configurations to accommodate anatomical variation. Self-tapping flutes help center the screw during insertion, while the chosen screw geometry defines its part in the fixation assembly.
Listed Item
Locking Screw (Cannulated Screw)
Screw Options
The system includes an Arch Screw configuration used with autograft and a Locking Screw configuration that can be used with or without a washer. These are different component options within the joint-fusion range.
3manufacturers in China registered for this device type
229catalogue numbers in this listing
4510(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 | L&K Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K231841 |
| Record published | 2023-07-25 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1025-8045 | In distribution | |
| 1022-1060S | In distribution | |
| 1025-8035S | In distribution | |
| 1023-7035 | In distribution | |
| 1022-1065S | In distribution | |
| 1025-7065S | In distribution | |
| 1022-1040 | In distribution | |
| 1203-0007 | In distribution | |
| 1024-2070 | In distribution | |
| 1025-8070S | In distribution | |
| 1024-2060S | In distribution | |
| BS65-0020 | In distribution | |
| 1023-6065S | In distribution | |
| 1022-1055S | In distribution | |
| 1024-2050 | In distribution | |
| 1024-2055S | In distribution | |
| BS65-0035S | In distribution | |
| 1022-2055S | In distribution | |
| 1023-6060S | In distribution | |
| 1022-2045S | In distribution | |
| 1023-7070 | In distribution | |
| 1024-2030S | In distribution | |
| 1022-2060 | In distribution | |
| 1023-6055S | In distribution | |
| 1023-7045 | In distribution | |
| 1023-8055 | In distribution | |
| BS65-0035 | In distribution | |
| 1025-8060S | In distribution | |
| 1025-7070S | In distribution | |
| BS65-0030 | In distribution | |
| 1025-8055S | In distribution | |
| 1022-2030 | In distribution | |
| 1025-8040 | In distribution | |
| BS13-0001S | In distribution | |
| 1022-2065S | In distribution | |
| 1024-2060 | In distribution | |
| 1203-0006 | In distribution | |
| 1023-7065 | In distribution | |
| 1025-8030 | In distribution | |
| 1024-2065S | In distribution | |
| 1023-8070S | In distribution | |
| 1023-7050S | In distribution | |
| 1023-8040 | In distribution | |
| 1024-2045 | In distribution | |
| 1025-7040 | In distribution | |
| 1025-7045S | In distribution | |
| 1024-2070 | In distribution | |
| BS65-0060S | In distribution | |
| 1022-1070S | In distribution | |
| 1023-7060 | In distribution | |
| 1023-6035 | In distribution | |
| 1023-8060S | In distribution | |
| 1025-7045S | In distribution | |
| BS65-0055 | In distribution | |
| 1022-2035 | In distribution | |
| 1022-1050S | In distribution | |
| 1025-8065 | In distribution | |
| 1023-7040S | In distribution | |
| 1025-7030 | In distribution | |
| 1024-2070S | In distribution | |
| 1023-7030S | In distribution | |
| BS65-0025 | In distribution | |
| 1025-7060 | In distribution | |
| 1024-2040 | In distribution | |
| 1024-2035S | In distribution | |
| 1023-8035S | In distribution | |
| 1025-7070S | In distribution | |
| 1025-7055 | In distribution | |
| 1023-8055S | In distribution | |
| BS65-0050 | In distribution | |
| 1023-8050S | In distribution | |
| 1025-8040 | In distribution | |
| 1025-8045S | In distribution | |
| 1023-7050 | In distribution | |
| 1023-8065 | In distribution | |
| 1023-8070 | In distribution | |
| 1025-7055S | In distribution | |
| 1025-8070S | In distribution | |
| 1022-1045 | In distribution | |
| 1025-7065 | In distribution | |
| BS65-0040 | In distribution | |
| 1025-7035 | In distribution | |
| 1025-7065 | In distribution | |
| 1022-2040 | In distribution | |
| 1023-8035 | In distribution | |
| 1023-0006 | In distribution | |
| 1203-0008S | In distribution | |
| 1023-8030S | In distribution | |
| 1025-7060 | In distribution | |
| 1023-6070S | In distribution | |
| 1023-6045 | In distribution | |
| 1025-8065S | In distribution | |
| 1025-8040S | In distribution | |
| BS65-0065S | In distribution | |
| 1025-7055S | In distribution | |
| 1024-2030 | In distribution | |
| 1025-8035 | In distribution | |
| BS65-0055S | In distribution | |
| 1024-2070S | In distribution | |
| BS65-0060 | In distribution | |
| 1203-0007 | In distribution | |
| 1023-6070 | In distribution | |
| 1023-8065S | In distribution | |
| 1025-8065 | In distribution | |
| BS65-0045 | In distribution | |
| 1023-6065 | In distribution | |
| 1025-8030S | In distribution | |
| 1025-8065S | In distribution | |
| 1022-1045S | In distribution | |
| 1025-8040S | In distribution | |
| 1024-2040S | In distribution | |
| BS65-0030S | In distribution | |
| 1025-7050 | In distribution | |
| 1024-2035 | In distribution | |
| 1024-2065 | In distribution | |
| 1025-8045 | In distribution | |
| 1023-7070S | In distribution | |
| 1025-7030S | In distribution | |
| 1025-8060S | In distribution | |
| 1025-7030 | In distribution | |
| 1023-6030 | In distribution | |
| 1025-8050 | In distribution | |
| BS65-0070S | In distribution | |
| 1025-8045S | In distribution | |
| 1025-7035S | In distribution | |
| 1023-7060S | In distribution | |
| 1024-2040 | In distribution | |
| BS65-0050S | In distribution | |
| 1025-7070 | In distribution | |
| 1022-2070S | In distribution | |
| 1025-8070 | In distribution | |
| 1022-2035S | In distribution | |
| 1025-8070 | In distribution | |
| 1022-1030 | In distribution | |
| 1025-8055S | In distribution | |
| 1025-7030S | In distribution | |
| 1023-8030 | In distribution | |
| 1023-0007 | In distribution | |
| 1025-7040 | In distribution | |
| 1022-1065 | In distribution | |
| 1025-7040S | In distribution | |
| 1022-1035S | In distribution | |
| BS65-0020S | In distribution | |
| 1024-2035 | In distribution | |
| 1024-2030 | In distribution | |
| 1023-8040S | In distribution | |
| 1022-2045 | In distribution | |
| 1024-2030S | In distribution | |
| BS65-0065 | In distribution | |
| 1025-8030S | In distribution | |
| 1024-2065S | In distribution | |
| 1022-1030S | In distribution | |
| 1025-8050 | In distribution | |
| 1024-2040S | In distribution | |
| 1025-8030 | In distribution | |
| 1023-6055 | In distribution | |
| 1023-6045S | In distribution | |
| 1023-8050 | In distribution | |
| 1023-6040S | In distribution | |
| 1022-1040S | In distribution | |
| 1024-2035S | In distribution | |
| 1025-7070 | In distribution | |
| 1025-7065S | In distribution | |
| 1023-6050 | In distribution | |
| 1024-2045 | In distribution | |
| 1025-8060 | In distribution | |
| 1022-2060S | In distribution | |
| 1025-7055 | In distribution | |
| 1024-2055S | In distribution | |
| 1025-8055 | In distribution | |
| 1024-2060 | In distribution | |
| 1024-2065 | In distribution | |
| 1025-8035 | In distribution | |
| BS65-0040S | In distribution | |
| 1022-2055 | In distribution | |
| 1023-6030S | In distribution | |
| 1024-2045S | In distribution | |
| 1023-8045 | In distribution | |
| 1023-7030 | In distribution | |
| 1023-7055 | In distribution | |
| 1023-6040 | In distribution | |
| 1025-7060S | In distribution | |
| 1023-7045S | In distribution | |
| 1023-7065S | In distribution | |
| 1025-8060 | In distribution | |
| 1024-2050 | In distribution | |
| 1024-2055 | In distribution | |
| 1023-6060 | In distribution | |
| 1023-7035S | In distribution | |
| 1022-2040S | In distribution | |
| 1024-2050S | In distribution | |
| 1024-2060S | In distribution | |
| 1022-1050 | In distribution | |
| 1203-0006 | In distribution | |
| 1022-2030S | In distribution | |
| 1022-2050 | In distribution | |
| 1203-0007S | In distribution | |
| 1025-7050 | In distribution | |
| 1025-7045 | In distribution | |
| 1023-6035S | In distribution | |
| BS65-0025S | In distribution | |
| 1025-8055 | In distribution | |
| BS65-0070 | In distribution | |
| 1023-7040 | In distribution | |
| 1022-1035 | In distribution | |
| 1025-7035S | In distribution | |
| 1024-2055 | In distribution | |
| 1022-2065 | In distribution | |
| 1025-7050S | In distribution | |
| 1024-2050S | In distribution | |
| 1025-7045 | In distribution | |
| 1025-8050S | In distribution | |
| 1203-0008 | In distribution | |
| 1025-7060S | In distribution | |
| 1023-6050S | In distribution | |
| 1024-2045S | In distribution | |
| 1022-1070 | In distribution | |
| 1025-7040S | In distribution | |
| 1022-2070 | In distribution | |
| 1022-2050S | In distribution | |
| 1023-7055S | In distribution | |
| 1025-7035 | In distribution | |
| 1203-0006S | In distribution | |
| 1022-1060 | In distribution | |
| BS13-0001 | In distribution | |
| 1025-8035S | In distribution | |
| 1022-1055 | In distribution | |
| 1023-8060 | In distribution | |
| 1023-8045S | 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 |
| 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 |
| Dynamis™ Implant System | Promethean Restorative Inc. | 120 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240201 | 2024-02-23 |
| K231841 | 2023-07-14 |
| K181600 | 2018-07-16 |
| K153656 | 2016-11-14 |
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.