Definition: Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion, Using Non-invasive Methods To Adjust The Spinal Rod.
| Device Type ID | 4752 |
| Device Name | Growing Rod System- Magnetic Actuation |
| Physical State | Metalllic Rods, Monoaxial Or Polyaxial Bone Screws, Hooks, Magnetic Remote Control, And Other Related Accessories. |
| Technical Method | The System Of Distracting Rods And Fixation Elements (screws, Hooks, Etc.) Provides Stabilization Of Severe Spinal Abnormalities And Distraction Of The Rod As The Child Grows, Via Magnetic Actuation. |
| 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 | PGN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4752 |
| Device | Growing Rod System- Magnetic Actuation |
| Product Code | PGN |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ELLIPSE TECHNOLOGIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELLIPSE TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Defective Device | 12 |
Break | 7 |
Pin | 3 |
Fracture | 2 |
Appropriate Term/Code Not Available | 2 |
No Apparent Adverse Event | 1 |
Defective Component | 1 |
Failure To Advance | 1 |
Rod | 1 |
Loose Or Intermittent Connection | 1 |
| Total Device Problems | 31 |