| Device |
orthopedic augmented reality |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view. |
| Physical State |
Display for augmenting information, stereotaxic navigation software, and associated surgical instruments. |
| Technical Method |
Visual guidance is shown through augmenting stereoscopic images while allowing view of the patient anatomy. The stereoscopic images are generated based on stereotaxic navigation software, where reference to rigid anatomical structures can be identified relative to patient imaging. This type of display should not include virtual reality, video see-through / pass-through, or holograms. |
| Target Area |
Orthopedic |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Orthopedic |
|---|
| Product Code | SBF |
|---|
| 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 |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
