Definition: Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.
| Device Type ID | 4751 |
| Device Name | Growing Rod System |
| Physical State | Metalllic Rods, Monoaxial Or Polyaxial Bone Screws, Hooks, And Other Related Accessories. |
| Technical Method | The System Of Distracting Or Compressing Rods And Fixation Elements (screws, Hooks, Etc.) Provides Stabilization And Correction Of The Spine As The Child Grows. |
| Target Area | Pediatric Spine. |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | PGM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4751 |
| Device | Growing Rod System |
| Product Code | PGM |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC SOFAMOR DANEK USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 4 |
Loose Or Intermittent Connection | 3 |
Migration Or Expulsion Of Device | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Fracture | 2 |
| Total Device Problems | 15 |