| Device Type ID | 4574 |
| Device Name | Appliance, Fixation, Spinal Interlaminal |
| Regulation Description | Spinal Interlaminal Fixation Orthosis. |
| 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 | 888.3050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4574 |
| Device | Appliance, Fixation, Spinal Interlaminal |
| Product Code | KWP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Interlaminal Fixation Orthosis. |
| CFR Regulation Number | 888.3050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CHOICE SPINE, LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EBI, L.P. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EBI, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JOHNSON & JOHNSON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JOHNSON AND JOHNSON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
L&K BIOMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OMNI SURGICAL LLC DBA SPINE360 | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOFIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SYNTHES USA PRODUCTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTHES USA PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 728 |
Failure To Align | 684 |
Migration Or Expulsion Of Device | 388 |
Adverse Event Without Identified Device Or Use Problem | 292 |
Device Slipped | 174 |
Fracture | 161 |
Loose Or Intermittent Connection | 117 |
Material Deformation | 108 |
Mechanical Problem | 106 |
Device Dislodged Or Dislocated | 88 |
Metal Shedding Debris | 79 |
Appropriate Term/Code Not Available | 74 |
Material Integrity Problem | 70 |
Migration | 52 |
Device Operates Differently Than Expected | 51 |
Unintended Movement | 44 |
Malposition Of Device | 28 |
Rod | 27 |
Detachment Of Device Or Device Component | 27 |
Torn Material | 22 |
Screw | 19 |
Detachment Of Device Component | 17 |
Device Damaged By Another Device | 17 |
Mechanical Jam | 17 |
Bent | 16 |
Peeled / Delaminated | 15 |
Insufficient Information | 15 |
Device Inoperable | 12 |
Failure To Adhere Or Bond | 11 |
Difficult To Remove | 11 |
Material Fragmentation | 8 |
Loosening Of Implant Not Related To Bone-Ingrowth | 8 |
Naturally Worn | 7 |
Biocompatibility | 7 |
Material Erosion | 6 |
Disassembly | 6 |
No Apparent Adverse Event | 6 |
Material Split, Cut Or Torn | 5 |
Use Of Device Problem | 5 |
Tip | 5 |
Device Operational Issue | 5 |
Device Markings / Labelling Problem | 5 |
Difficult To Position | 4 |
Failure To Osseointegrate | 4 |
Connection Problem | 4 |
Unstable | 3 |
Corroded | 3 |
Packaging Problem | 3 |
Disconnection | 3 |
Connector | 3 |
Difficult To Insert | 3 |
Device Handling Problem | 3 |
Unsealed Device Packaging | 2 |
Inaccurate Information | 2 |
Material Separation | 2 |
Out-Of-Box Failure | 2 |
Incomplete Or Missing Packaging | 2 |
Device-Device Incompatibility | 2 |
Flaked | 2 |
Positioning Problem | 2 |
Thread | 2 |
Shelf Life Exceeded | 2 |
Collapse | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Contamination During Use | 2 |
Material Disintegration | 2 |
Fastener | 1 |
Patient-Device Incompatibility | 1 |
Problem With Sterilization | 1 |
Material Twisted / Bent | 1 |
Device Deployer | 1 |
Failure To Capture | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Shaft | 1 |
Unintended System Motion | 1 |
Component Missing | 1 |
Difficult To Open Or Close | 1 |
Heads | 1 |
Degraded | 1 |
Crack | 1 |
Device Expiration Issue | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Missing Value Reason | 1 |
Scratched Material | 1 |
Material Distortion | 1 |
Mechanics Altered | 1 |
Failure To Disconnect | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Leak / Splash | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Loss Of Osseointegration | 1 |
Battery Charger, Defective | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Device Packaging Compromised | 1 |
Material Protrusion / Extrusion | 1 |
Material Torqued | 1 |
| Total Device Problems | 3638 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet Spine, LLC | II | Sep-10-2015 |
| 2 | Biomet, Inc. | II | May-26-2016 |
| 3 | Medacta Usa Inc | II | Jan-13-2017 |
| 4 | Orthofix, Inc. | II | Jan-28-2014 |
| 5 | PIONEER SURGICAL TECHNOLOGY, INC. | II | Sep-03-2014 |
| 6 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | II | Oct-11-2018 |
| 7 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | II | Oct-20-2016 |
| 8 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | II | May-26-2016 |
| 9 | Zimmer Biomet Spine Inc. | II | Feb-22-2019 |
| 10 | Zimmer Biomet, Inc. | II | Jan-09-2016 |
| 11 | Zimmer Spine, Inc. | II | Feb-26-2016 |
| 12 | Zimmer, Inc. | II | Dec-12-2014 |