| Device Type ID | 4486 |
| Device Name | Pin, Fixation, Smooth |
| 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 | HTY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4486 |
| Device | Pin, Fixation, Smooth |
| Product Code | HTY |
| 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 | |
ADDITIVE ORTHOPAEDICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BEIJING NATON TECHNOLOGY GROUP CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMEDICAL ENTERPRISES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIORETEC LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED CORPORATION, LARGO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IN2BONES SAS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
METRIC MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEWCLIP TECHNICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVASTEP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOFIX SRL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOHELIX SURGICAL DESIGN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARAGON 28 | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECIFIT MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINAL RESOURCES INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SYNCHRO MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TORNIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WRIGHT MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 96 |
Adverse Event Without Identified Device Or Use Problem | 63 |
Mechanical Jam | 31 |
Fracture | 25 |
Separation Failure | 8 |
Migration Or Expulsion Of Device | 7 |
Bent | 7 |
Device Operates Differently Than Expected | 6 |
Material Fragmentation | 6 |
Fitting Problem | 4 |
Insufficient Information | 4 |
Difficult To Advance | 4 |
Appropriate Term/Code Not Available | 4 |
Use Of Device Problem | 3 |
Component Missing | 3 |
Material Integrity Problem | 3 |
Difficult To Insert | 3 |
Unintended Movement | 3 |
Physical Resistance / Sticking | 3 |
Patient Device Interaction Problem | 3 |
Failure To Align | 2 |
Shelf Life Exceeded | 2 |
Naturally Worn | 2 |
Failure To Advance | 2 |
Product Quality Problem | 2 |
Patient-Device Incompatibility | 2 |
Shipping Damage Or Problem | 2 |
Material Puncture / Hole | 1 |
Difficult To Open Or Close | 1 |
Misassembled | 1 |
Difficult To Remove | 1 |
Device Operational Issue | 1 |
Material Twisted / Bent | 1 |
Unstable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Pin | 1 |
Migration | 1 |
Device Slipped | 1 |
Premature Activation | 1 |
Detachment Of Device Or Device Component | 1 |
Missing Value Reason | 1 |
Material Rupture | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Entrapment Of Device | 1 |
Device Packaging Compromised | 1 |
Material Protrusion / Extrusion | 1 |
Device-Device Incompatibility | 1 |
Shaft Break | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Sticking | 1 |
| Total Device Problems | 324 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Acumed LLC | II | Apr-25-2014 |
| 2 | Amendia, Inc | II | Dec-22-2016 |
| 3 | Biomet, Inc. | II | May-26-2016 |
| 4 | MicroAire Surgical Instruments, LLC | II | Mar-03-2017 |
| 5 | Zimmer Biomet, Inc. | II | Jun-01-2018 |
| 6 | Zimmer Biomet, Inc. | II | Oct-14-2016 |