Definition: The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
| Device Type ID | 4688 |
| Device Name | Bone Cement, Posterior Screw Augmentation |
| Physical State | Viscous, Polymethylmethacrylate Material That Set Hardens Over Time. |
| Technical Method | The Device Is Placed Within The Prepared Bone Canal For Placement Of The Posterior Screw, And Can Be Delivered Through The Screw Cannulation And Fenestrations. |
| Target Area | Prepared Bone Canal In The Posterior Spine For Placement Of A Screw. |
| 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 | PML |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4688 |
| Device | Bone Cement, Posterior Screw Augmentation |
| Product Code | PML |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| CFR Regulation Number | 888.3027 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 15 |
Loose Or Intermittent Connection | 12 |
Disconnection | 4 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Appropriate Term/Code Not Available | 1 |
Disassembly | 1 |
Torn Material | 1 |
Material Deformation | 1 |
| Total Device Problems | 39 |