| Device Type ID | 4530 |
| Device Name | Cerclage, Fixation |
| Regulation Description | Bone Fixation Cerclage. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JDQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4530 |
| Device | Cerclage, Fixation |
| Product Code | JDQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Fixation Cerclage. |
| CFR Regulation Number | 888.3010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DSM BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRONTIER MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
KLS MARTIN GMBH + CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KLS MARTIN GMBH And CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIONEER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIONEER SURGICAL TECHNOLOGY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 149 |
Adverse Event Without Identified Device Or Use Problem | 140 |
Break | 114 |
Insufficient Information | 44 |
Mechanical Problem | 31 |
Fracture | 29 |
Unintended Movement | 15 |
Failure To Adhere Or Bond | 12 |
Component Missing | 12 |
Mechanical Jam | 11 |
Bent | 8 |
Sticking | 7 |
Device-Device Incompatibility | 7 |
Material Deformation | 6 |
Loose Or Intermittent Connection | 6 |
Device Dislodged Or Dislocated | 5 |
Migration Or Expulsion Of Device | 4 |
Device Operational Issue | 4 |
Material Integrity Problem | 4 |
Dull, Blunt | 4 |
Device Handling Problem | 4 |
Device Issue | 4 |
Material Fragmentation | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Corroded | 3 |
Appropriate Term/Code Not Available | 3 |
Material Frayed | 3 |
Difficult To Open Or Close | 2 |
Cable | 2 |
Incorrect Device Or Component Shipped | 2 |
Device Packaging Compromised | 2 |
Difficult To Insert | 2 |
Detachment Of Device Or Device Component | 2 |
Packaging Problem | 1 |
Difficult To Position | 1 |
Microbial Contamination Of Device | 1 |
Defective Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Material Distortion | 1 |
Positioning Problem | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Plate | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Detachment Of Device Component | 1 |
Fitting Problem | 1 |
Loss Of Osseointegration | 1 |
Material Disintegration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Contamination During Use | 1 |
No Apparent Adverse Event | 1 |
Failure To Cut | 1 |
Activation, Positioning Or Separation Problem | 1 |
Disassembly | 1 |
Device Difficult To Setup Or Prepare | 1 |
Use Of Device Problem | 1 |
Unraveled Material | 1 |
Device Difficult To Maintain | 1 |
| Total Device Problems | 673 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 2 | PIONEER SURGICAL TECHNOLOGY, INC. | II | Jul-17-2014 |
| 3 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | II | Jul-09-2015 |
| 4 | Synthes (USA) Products LLC | II | Nov-14-2015 |
| 5 | Synthes (USA) Products LLC | II | Aug-27-2015 |