| Device |
pin, fixation, resorbable, hard tissue |
| Regulation Description |
Smooth or threaded metallic bone fixation fastener. |
| Definition |
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications. |
| Physical State |
Supplied with various surgical instruments, may include stainless steel applicator tube, wire, gauge, pin plunger, arthroscopic kit. |
| Technical Method |
This is a device that consists of a stiff wire segment or rod made of resorbable polymer and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. The device is intended to be implanted either through fracture fragments, intramedullary canal, or across a joint, and temporarily provide stabilization while healing or fusion occurs. |
| Target Area |
For various anatomic locations including knee, hand, finger and toe. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | OVZ |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3040
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
|
|
