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 |