Definition: Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
| Device Type ID | 4671 |
| Device Name | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Physical State | Hollow Cylinder Or Rectangular Box Made Of Metal Or Polymer With Integrated Fixation. |
| Technical Method | Acts As A Disc Spacer And Holds Bone Graft; Also Includes Some Form Of Integrated Fixation To Maintain Stability By Direct Purchase Into The Bony Vertebral Endplates. |
| Target Area | Intervertebral Disc Space |
| Regulation Description | Intervertebral Body Fusion Device. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3080 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4671 |
| Device | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Product Code | OVD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intervertebral Body Fusion Device. |
| CFR Regulation Number | 888.3080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMENDIA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOGENNIX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAMBER SPINE/MEDICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CENTINEL SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CHOICE SPINE, LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CUSTOM SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FBC DEVICE APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRONTIER MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
GLOBUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LDR SPINE USA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LDR SPINE USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDICREA INTERNATIONAL S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC SOFAMOR DANEK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEUROSTRUCTURES, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHOFIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEO VASIVE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIATS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINE WAVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEOLOGY INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SURGICAL INSTRUMENT MANUFACTURERS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TITAN SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XTANT MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZAVATION, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET SPINE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 51 |
Break | 36 |
Migration Or Expulsion Of Device | 21 |
Fracture | 19 |
Screw | 14 |
Unintended Movement | 11 |
Disassembly | 10 |
Material Deformation | 8 |
Mechanical Problem | 7 |
Appropriate Term/Code Not Available | 6 |
Bent | 6 |
Material Integrity Problem | 5 |
Crack | 5 |
Insufficient Information | 5 |
Knife | 3 |
Positioning Failure | 3 |
Material Fragmentation | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Device Operates Differently Than Expected | 3 |
No Apparent Adverse Event | 3 |
Tip | 2 |
Failure To Advance | 2 |
Migration | 2 |
Device Handling Problem | 2 |
Failure To Align | 2 |
Loose Or Intermittent Connection | 2 |
Positioning Problem | 2 |
Difficult To Insert | 1 |
Malposition Of Device | 1 |
Split | 1 |
Detachment Of Device Or Device Component | 1 |
Device Expiration Issue | 1 |
Collapse | 1 |
Spacer | 1 |
Plate | 1 |
Incomplete Or Missing Packaging | 1 |
Device Damaged By Another Device | 1 |
Material Torqued | 1 |
Detachment Of Device Component | 1 |
Fitting Problem | 1 |
Device Component Or Accessory | 1 |
Patient-Device Incompatibility | 1 |
Use Of Device Problem | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 253 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Amendia, Inc | II | Dec-22-2016 |
| 2 | Biomet Spine, LLC | II | Mar-25-2016 |
| 3 | Biomet Spine, LLC | II | Jan-15-2015 |
| 4 | Biomet Spine, LLC | II | Jan-15-2015 |
| 5 | Biomet Spine, LLC | II | Jan-14-2015 |
| 6 | VGI Medical, LLC | II | Jun-05-2018 |