| Device Type ID | 4534 |
| Device Name | Pin, Fixation, Threaded |
| 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 | JDW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4534 |
| Device | Pin, Fixation, Threaded |
| Product Code | JDW |
| 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 | |
GENOSSIS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VILEX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Mechanical Problem | 40 |
Break | 37 |
Patient Device Interaction Problem | 34 |
Fracture | 32 |
Bent | 9 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Tip | 9 |
Dull, Blunt | 9 |
Mechanical Jam | 7 |
Material Fragmentation | 5 |
Detachment Of Device Component | 5 |
Insufficient Information | 5 |
Cutter | 5 |
Pin | 5 |
Product Quality Problem | 4 |
Crack | 4 |
Detachment Of Device Or Device Component | 3 |
Material Integrity Problem | 3 |
Difficult To Remove | 2 |
Device Operates Differently Than Expected | 2 |
Human-Device Interface Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Screw | 2 |
Component Missing | 2 |
Difficult To Advance | 2 |
Unintended Movement | 2 |
Device Packaging Compromised | 2 |
Device Damaged By Another Device | 1 |
Device Maintenance Issue | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Device-Device Incompatibility | 1 |
Incorrect Device Or Component Shipped | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Positioning Problem | 1 |
Switch, Push Button | 1 |
Device Markings / Labelling Problem | 1 |
Connector | 1 |
Entrapment Of Device | 1 |
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Collapse | 1 |
Material Frayed | 1 |
Contamination / Decontamination Problem | 1 |
Material Twisted / Bent | 1 |
Failure To Osseointegrate | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
| Total Device Problems | 264 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Musculoskeletal Transplant Foundation, Inc. | II | Jul-24-2015 |
| 2 | Zimmer Biomet, Inc. | II | Dec-29-2017 |