| Device |
pedicle screw placement guide |
| Regulation Description |
Thoracolumbosacral pedicle screw system. |
| Definition |
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans. |
| Physical State |
A pedicle 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 pedicle screws in a pre-operatively desired orientation. |
| Target Area |
Spine |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | PQC |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3070
|
|---|
| 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 |
