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 Tota
| Device Type ID | 4455 |
| Device Name | Orthopedic Computer Controlled Surgical System |
| 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 Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OJP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4455 |
| Device | Orthopedic Computer Controlled Surgical System |
| Product Code | OJP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CUREXO TECHNOLOGY CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
THINK SURGICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |