| Device |
implantable post-surgical kinematic measurement knee device |
| Regulation Description |
Implantable post-surgical kinematic measurement knee device. |
| Definition |
An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery. |
| Physical State |
The device system includes the physical implant with embedded software, electronics, and accessories that support data transmission and collection. |
| Technical Method |
The implant’s sensors (for example, accelerometers and gyrometers) measure the patient’s leg and lower limb movement. The data is then transferred via wireless communication to external devices for collection, evaluation, and review. |
| Target Area |
Knee joint |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QPP |
|---|
| Premarket Review |
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3600
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
