Definition: Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.
| Device Type ID | 4668 |
| Device Name | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Physical State | Bone Screws, Rods, And Hooks Intended To Stabilize The Spine As An Adjunct To Fusion |
| Technical Method | Acts As A Spinal Fusion System With Autograft And/or Allograft To Stabilize The Spine As An Adjunct To Fusion To Treat Adolescent Idiopathic Scoliosis |
| Target Area | Posterior, Non-cervical Spinal Column In Adolescent Patients |
| Regulation Description | Thoracolumbosacral Pedicle Screw System. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4668 |
| Device | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Product Code | OSH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thoracolumbosacral Pedicle Screw System. |
| CFR Regulation Number | 888.3070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASTURA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC SOFAMOR DANEK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fracture | 8 |
Detachment Of Device Component | 4 |
Device Issue | 4 |
Material Integrity Problem | 3 |
Migration | 3 |
Material Separation | 2 |
Rod | 2 |
Break | 2 |
Insufficient Information | 1 |
Disconnection | 1 |
Malposition Of Device | 1 |
Mechanical Jam | 1 |
Unintended Movement | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 35 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | OrthoPediatrics Corp | II | Feb-14-2018 |