| Device Type ID | 4624 |
| Device Name | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4624 |
| Device | Orthosis, Spinal Pedicle Fixation |
| Product Code | MNI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thoracolumbosacral Pedicle Screw System. |
| CFR Regulation Number | 888.3070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CG BIO CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K7 LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KISCO INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICREA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEW ERA ORTHOPAEDICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINE WAVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPINEVISION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 128 |
Adverse Event Without Identified Device Or Use Problem | 76 |
Fracture | 72 |
Migration Or Expulsion Of Device | 47 |
Mechanical Problem | 38 |
Material Integrity Problem | 31 |
Device Dislodged Or Dislocated | 29 |
Material Separation | 24 |
Loose Or Intermittent Connection | 23 |
Unintended Movement | 21 |
Screw | 20 |
Device Operates Differently Than Expected | 16 |
Material Fragmentation | 15 |
Detachment Of Device Or Device Component | 14 |
Insufficient Information | 14 |
Failure To Adhere Or Bond | 14 |
Disassembly | 13 |
Detachment Of Device Component | 12 |
Material Deformation | 9 |
Device Operational Issue | 9 |
No Apparent Adverse Event | 8 |
Appropriate Term/Code Not Available | 8 |
Rod | 6 |
Torn Material | 5 |
Device Slipped | 5 |
Loosening Of Implant Not Related To Bone-Ingrowth | 5 |
Device Damaged By Another Device | 4 |
Difficult To Position | 4 |
Malposition Of Device | 4 |
Material Twisted / Bent | 4 |
Migration | 4 |
Improper Or Incorrect Procedure Or Method | 3 |
Bent | 3 |
Defective Device | 3 |
Packaging Problem | 2 |
Difficult To Insert | 2 |
Device Damaged Prior To Use | 2 |
Mechanical Jam | 2 |
Device-Device Incompatibility | 2 |
Difficult To Remove | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Use Of Device Problem | 2 |
Connection Problem | 2 |
Contamination / Decontamination Problem | 1 |
Component Missing | 1 |
Cannula, Inner | 1 |
Loss Of Or Failure To Bond | 1 |
Unstable | 1 |
Cap | 1 |
Measurement System Incompatibility | 1 |
Prong | 1 |
Material Torqued | 1 |
Ring | 1 |
Separation Failure | 1 |
Connector | 1 |
Spacer | 1 |
Naturally Worn | 1 |
Thread | 1 |
| Total Device Problems | 724 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CTL Medical Corporation | II | Mar-20-2019 |
| 2 | Exactech, Inc. | II | Mar-18-2014 |
| 3 | New Era Orthopaedics, LLc | II | Aug-03-2018 |
| 4 | Synthes (USA) Products LLC | II | Oct-17-2015 |
| 5 | Valorem Surgical LLC | II | Aug-10-2017 |