| Device Type ID | 4532 |
| Device Name | Nail, Fixation, Bone |
| 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 | JDS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4532 |
| Device | Nail, Fixation, Bone |
| Product Code | JDS |
| 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 | |
CONVENTUS ORTHOPAEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 595 |
Break | 217 |
Migration Or Expulsion Of Device | 64 |
Fracture | 48 |
Insufficient Information | 46 |
Device-Device Incompatibility | 34 |
Unintended Movement | 30 |
Failure To Align | 27 |
Device Operates Differently Than Expected | 24 |
Appropriate Term/Code Not Available | 22 |
Fitting Problem | 19 |
Mechanical Jam | 16 |
Bent | 16 |
Material Fragmentation | 9 |
Sticking | 9 |
Difficult To Remove | 7 |
Material Twisted / Bent | 6 |
Failure To Adhere Or Bond | 5 |
Migration | 5 |
Connection Problem | 5 |
Material Deformation | 5 |
Detachment Of Device Or Device Component | 5 |
Device Slipped | 5 |
Separation Failure | 4 |
Screw | 4 |
No Apparent Adverse Event | 3 |
Device Difficult To Maintain | 3 |
Mechanical Problem | 3 |
Difficult To Position | 3 |
Loose Or Intermittent Connection | 3 |
Crack | 2 |
Packaging Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Use Of Device Problem | 2 |
Device Operational Issue | 2 |
Failure To Osseointegrate | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Material Integrity Problem | 1 |
Component Missing | 1 |
Degraded | 1 |
Disassembly | 1 |
Tip | 1 |
Component Misassembled | 1 |
Misassembled | 1 |
Torn Material | 1 |
Noise, Audible | 1 |
Device Expiration Issue | 1 |
Naturally Worn | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Shelf Life Exceeded | 1 |
Device Markings / Labelling Problem | 1 |
Difficult To Advance | 1 |
Positioning Problem | 1 |
Difficult To Insert | 1 |
Device Damaged By Another Device | 1 |
Material Protrusion / Extrusion | 1 |
Patient Device Interaction Problem | 1 |
Plate | 1 |
Physical Resistance / Sticking | 1 |
| Total Device Problems | 1277 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Smith & Nephew Inc | II | May-20-2014 |
| 2 | Smith & Nephew, Inc. | II | Nov-16-2017 |
| 3 | Smith & Nephew, Inc. | II | Aug-17-2014 |
| 4 | Synthes, Inc. | II | Jul-08-2015 |
| 5 | Zimmer Biomet, Inc. | II | Mar-27-2017 |