| Device |
intra-articular orthopedic stereotaxic navigation instrument |
| Definition |
An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices. |
| Physical State |
Device consists of control unit or processing hardware, rigid fiducial tracking markers, device-specific instruments, and an interface for communication between user and device. Compatible with arthroscopic systems (e.g., camera, camera controller, and fluid management system) to enable intraarticular marker detection, spatial tracking, and surgical procedure. |
| Technical Method |
User loads software preoperatively to plan surgery procedure, user intraoperatively places patient tracking marker within intraarticular joint space, then registers the patient anatomy during surgery to allow software to continuously track patient anatomy, implants, and surgical tools in real time/space. |
| Target Area |
Orthopedic joints where intraarticular tracking of instrumentation is desired. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | SIQ |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.4561
|
|---|
| 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 |
