| Device Type ID | 4611 |
| Device Name | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MAI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4611 |
| Device | Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code | MAI |
| 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 | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
CONMED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CONMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DEPUY INTL., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDOS INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
NANOVA BIOMATERIALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARCUS MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Break | 1251 |
Migration Or Expulsion Of Device | 107 |
Activation, Positioning Or Separation Problem | 107 |
Positioning Failure | 89 |
Fracture | 68 |
Material Frayed | 62 |
Material Twisted / Bent | 56 |
Adverse Event Without Identified Device Or Use Problem | 51 |
Crack | 43 |
Deformation Due To Compressive Stress | 33 |
Insufficient Information | 30 |
Mechanical Jam | 25 |
Device-Device Incompatibility | 25 |
Material Split, Cut Or Torn | 25 |
Migration | 23 |
Premature Activation | 21 |
Failure To Advance | 20 |
Activation Problem | 20 |
Bent | 17 |
Difficult To Insert | 15 |
Separation Failure | 15 |
Firing Problem | 14 |
Mechanical Problem | 14 |
Appropriate Term/Code Not Available | 13 |
Material Deformation | 11 |
Material Fragmentation | 10 |
Detachment Of Device Component | 9 |
Detachment Of Device Or Device Component | 9 |
Loss Of Or Failure To Bond | 9 |
Difficult Or Delayed Positioning | 9 |
Failure To Fire | 8 |
Loosening Of Implant Not Related To Bone-Ingrowth | 7 |
Positioning Problem | 6 |
Failure To Adhere Or Bond | 6 |
Device Operates Differently Than Expected | 6 |
Misfire | 6 |
Patient-Device Incompatibility | 5 |
Entrapment Of Device | 5 |
Device Damaged By Another Device | 5 |
Patient Device Interaction Problem | 5 |
Unintended Movement | 4 |
Use Of Device Problem | 4 |
Suture | 3 |
Physical Resistance / Sticking | 3 |
Expulsion | 3 |
Loose Or Intermittent Connection | 3 |
Material Rupture | 3 |
Failure To Disconnect | 2 |
Difficult To Advance | 2 |
Program Or Algorithm Execution Problem | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Suction Failure | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 2 |
Material Invagination | 2 |
Device Dislodged Or Dislocated | 2 |
Failure To Eject | 1 |
Screw | 1 |
Arcing Of Electrodes | 1 |
Component Missing | 1 |
Overfill | 1 |
Connection Problem | 1 |
Unraveled Material | 1 |
Electrical /Electronic Property Problem | 1 |
Wire | 1 |
Cuff | 1 |
Material Integrity Problem | 1 |
Operating System Becomes Nonfunctional | 1 |
Difficult To Remove | 1 |
Loss Of Osseointegration | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Scratched Material | 1 |
Device Markings / Labelling Problem | 1 |
Component Falling | 1 |
Malfunction | 1 |
Separation Problem | 1 |
Nonstandard Device | 1 |
Difficult To Position | 1 |
Device Slipped | 1 |
Device Expiration Issue | 1 |
Filling Problem | 1 |
| Total Device Problems | 2325 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrex, Inc. | II | May-05-2017 |
| 2 | Smith & Nephew, Inc. | II | Apr-26-2018 |
| 3 | Smith & Nephew, Inc. | II | Sep-07-2016 |