| Device |
sacroiliac screw placement guide |
| Regulation Description |
Smooth or threaded metallic bone fixation fastener. |
| Definition |
A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans. |
| Physical State |
A sacroiliac screw placement guide, made of polymeric or metallic material, which contains a patient-matched surface that is congruent to the mating surface of the posterior elements of the spine. |
| Technical Method |
The device consists of a both a software and hardware component. The software component generates a pre-operative plan based on medical imaging data. The hardware component consists of a patient-matched guide that is positioned onto the posterior elements of the spine. The guide is used to place sacroiliac screws in a pre-operatively desired orientation. |
| Target Area |
Sacroiliac joint |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QSR |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3040
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
