Definition: Intended For Small Bone Fixation In Fracture, Osteotomy, And Arthrodesis Applications.
| Device Type ID | 4673 |
| Device Name | Pin, Fixation, Resorbable, Hard Tissue |
| 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, Slott |
| Target Area | For Various Anatomic Locations Including Knee, Hand, Finger And Toe. |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4673 |
| Device | Pin, Fixation, Resorbable, Hard Tissue |
| Product Code | OVZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| CFR Regulation Number | 888.3040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fracture | 4 |
Component Missing | 2 |
Difficult Or Delayed Positioning | 1 |
Migration Or Expulsion Of Device | 1 |
Pin | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 10 |