| Device Type ID | 4478 |
| Device Name | Washer, Bolt Nut |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| 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 | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HTN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4478 |
| Device | Washer, Bolt Nut |
| Product Code | HTN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| CFR Regulation Number | 888.3030 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AKROS MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROSURFACE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DALLEN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MEDSHAPE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTISE MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOHELIX SURGICAL DESIGN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TORNIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WRIGHT MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XIROS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 37 |
Break | 7 |
Difficult To Position | 5 |
Appropriate Term/Code Not Available | 5 |
Insufficient Information | 4 |
Expulsion | 3 |
Fracture | 3 |
Migration Or Expulsion Of Device | 3 |
Device Operates Differently Than Expected | 2 |
Component Missing | 2 |
Fitting Problem | 2 |
Unintended Movement | 2 |
Failure To Align | 2 |
Delivery System Failure | 1 |
Difficult To Advance | 1 |
Knotted | 1 |
Mechanical Jam | 1 |
Misassembly By Users | 1 |
Material Fragmentation | 1 |
Separation Failure | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 85 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrex, Inc. | III | Sep-30-2016 |