| Device |
orthopedic computer controlled surgical system |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA). |
| Physical State |
Preoperative Planning Workstation, a robotic arm, electronics control cabinet, display monitor and miscellaneous accessories (such as cutters, drapes, irrigation sets, probes and markers). |
| Technical Method |
The system registers patient anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femeral canal for primary total hip arthroplasty. |
| Target Area |
Orthopedic Surgery - Hard tissue. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Orthopedic |
|---|
| Product Code | OJP |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4560
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
