Definition: Sacroiliac Joint Fusion
| Device Type ID | 4670 |
| Device Name | Sacroiliac Joint Fixation |
| Physical State | May Be Used With Bone Graft, Should Not Be Used With Bone Cement |
| Technical Method | Bridges Both Sides Of The Joint, Preventing Motion |
| Target Area | Sacroiliac Joint |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4670 |
| Device | Sacroiliac Joint Fixation |
| Product Code | OUR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| CFR Regulation Number | 888.3040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAMBER SPINE/MEDICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
L&K BIOMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC SOFAMOR DANEK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SI-BONE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
SI-TECHNOLOGY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEFRONTIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEFRONTIER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SURGICAL INSTRUMENT MANUFACTURERS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XTANT MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZYGA TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Malposition Of Device | 241 |
Adverse Event Without Identified Device Or Use Problem | 177 |
Failure To Osseointegrate | 25 |
Loss Of Osseointegration | 20 |
Inadequacy Of Device Shape And/or Size | 8 |
Device Handling Problem | 7 |
Break | 5 |
Device Damaged By Another Device | 4 |
Difficult To Remove | 4 |
Insufficient Information | 3 |
Use Of Device Problem | 2 |
Tip | 1 |
Fracture | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Difficult To Advance | 1 |
Difficult To Insert | 1 |
| Total Device Problems | 501 |