| Device |
instruments designed for press-fit osteochondral implants |
| Regulation Description |
Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation. |
| Definition |
The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants. |
| Physical State |
Smooth, metallic, with implant-specific geometry |
| Technical Method |
Used as manual surgical instruments for press-fit osteochondral implants |
| Target Area |
Bones of the extremities |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QBO |
|---|
| Premarket Review |
Restorative, Repair and Trauma Devices
(DHT6C)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
888.4505
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
