| Device Type ID | 4640 |
| Device Name | Cement, Bone, Vertebroplasty |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| 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 | 888.3027 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NDN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4640 |
| Device | Cement, Bone, Vertebroplasty |
| Product Code | NDN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| CFR Regulation Number | 888.3027 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BENVENUE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BM KOREA CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMEDICOM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMEDICOM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC SOFAMOR DANCK USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PAN MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZAVATION LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 103 |
Migration Or Expulsion Of Device | 80 |
Appropriate Term/Code Not Available | 77 |
Adverse Event Without Identified Device Or Use Problem | 72 |
Device Operates Differently Than Expected | 51 |
Break | 48 |
Chemical Problem | 31 |
Material Too Rigid Or Stiff | 22 |
Fluid Leak | 13 |
Failure To Eject | 10 |
Migration | 9 |
No Flow | 8 |
Use Of Device Problem | 6 |
Burst Container Or Vessel | 6 |
Fracture | 5 |
Filling Problem | 5 |
Mechanical Jam | 4 |
Coagulation In Device Or Device Ingredient | 4 |
Device Difficult To Setup Or Prepare | 3 |
Difficult To Open Or Close | 3 |
Positioning Failure | 3 |
Sticking | 3 |
Delivery System Failure | 3 |
Crack | 3 |
Device Expiration Issue | 2 |
Mechanical Problem | 2 |
Shelf Life Exceeded | 2 |
Insufficient Information | 2 |
Difficult To Insert | 2 |
Improper Chemical Reaction | 2 |
Fitting Problem | 2 |
Decrease In Pressure | 2 |
Activation, Positioning Or Separation Problem | 2 |
Tip | 2 |
Material Integrity Problem | 2 |
Failure To Adhere Or Bond | 2 |
Clumping In Device Or Device Ingredient | 2 |
Unstable | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Advance | 1 |
Ambient Temperature Problem | 1 |
Failure To Cycle | 1 |
Difficult To Remove | 1 |
No Apparent Adverse Event | 1 |
Material Puncture / Hole | 1 |
Component Missing | 1 |
Structural Problem | 1 |
Delivered As Unsterile Product | 1 |
Activation Failure Including Expansion Failures | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Detachment Of Device Component | 1 |
Pressure Problem | 1 |
Unintended Movement | 1 |
Misassembly By Users | 1 |
Incomplete Or Missing Packaging | 1 |
Loose Or Intermittent Connection | 1 |
Material Rupture | 1 |
Insufficient Flow Or Under Infusion | 1 |
Difficult To Advance | 1 |
Detachment Of Device Or Device Component | 1 |
Packaging Problem | 1 |
Failure To Align | 1 |
Collapse | 1 |
| Total Device Problems | 624 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DePuy Spine, Inc. | II | Apr-03-2018 |
| 2 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-28-2018 |
| 3 | Stryker Instruments Div. Of Stryker Corporation | II | Aug-15-2016 |