12 X 72.5MM SI Fusion Fastener Cann
The Integrity-SI fusion fastener stabilizes the sacroiliac joint during arthrodesis when used with autograft or allograft. It is a self-tapping, cannulated titanium implant inserted across…
The Integrity-SI fusion fastener stabilizes the sacroiliac joint during arthrodesis when used with autograft or allograft. It is a self-tapping, cannulated titanium implant inserted across the joint. The listed 12 mm by 72.5 mm fastener falls within the primary screw range.
The primary screws are available with partial or full threading and include a preassembled washer for joint compression. The cannulation supports placement within the surgical construct. Optional secondary fasteners provide additional rotational stability when used with a primary screw.
Indications
Uses include sacroiliac dysfunction from disruption or degenerative sacroiliitis, including symptoms that began during pregnancy or the peripartum period and persisted more than six months postpartum. Other indications cover sacropelvic stabilization in skeletally mature patients and fractures involving the sacroiliac joint.
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 | OsteoCentric Technologies,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) | K230226 |
| Record published | 2023-10-04 |
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 |
| Sizes | Outer diameter 12 mm; length 72.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 202-12072 | 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 |
|---|---|
| K230226 | 2023-09-21 |
| K222512 | 2022-09-12 |
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.