Definition: Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
| Device Type ID | 4612 |
| Device Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Physical State | Hollow Cylinder Or Rectangular Box Made Of Metal Or Polymer |
| Technical Method | Acts As A Disc Spacer And Holds Bone Graft. |
| 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 | MAX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4612 |
| Device | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Product Code | MAX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intervertebral Body Fusion Device. |
| CFR Regulation Number | 888.3080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
4WEB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP IMPLANT SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALLIANCE PARTNERS, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALPHATEC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ALPHATEC HOLDINGS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
AMEDICA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
AMENDIA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ASTURA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ATLAS SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AURORA SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BENVENUE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIEDERMANN MOTECH GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOGENNIX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET SPINE LLC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BK MEDITECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAMBER SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAMBER SPINE/MEDICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAPTIVA SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CENTINEL SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHOICE SPINE, LP | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
COGENT SPINE LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CORENTEC CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CUSTOM SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CUTTING EDGE SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DEPUY SYNTHES SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEROYAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEROYAL INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EISERTECH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVOLUTION SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EXPANDING ORTHOPEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GENESYS SPINE | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
GS MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HT MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INFRONT MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVA SPINAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
INNOVASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INTEGRITY IMPLANTS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERVENTIONAL SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
JOIMAX GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
K2M, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
KEOS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KUROS BIOSCIENCES BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
L&K BIOMED CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
L&K BIOMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MEDACTA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL DESIGNS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICREA INTERNATIONAL S.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDITECH SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDOS INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDOS INTERNATIONAL, SARL | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
MEDTRONIC SOFAMOR DANEK | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 14 | |
MEDYSSEY USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MET 1 TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEO MEDICAL S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOORTHO PRODUTOS ORTOPEDICOS S/A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROPRO SPINAL JAXX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROSTRUCTURES, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEXUS SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NLT SPINE LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NUVASIVE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NUVASIVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 20 | |
NVISION BIOMEDICAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ORTHOFIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
OSSEUS FUSION SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OUROBOROS MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PINNACLE SPINE GROUP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
PIONEER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIONEER SURGICAL TECHNOLOGY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECIFIT MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PRECISION SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RENOVIS SURGICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
RTI SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAFE ORTHOPAEDICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
SIGNUS MEDIZINTECHNIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SILONY MEDICAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SINTEA PLUSTEK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINE WAVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
SPINEFRONTIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEFRONTIER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEOLOGY INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
SPINEOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
SPINEVIEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEVISION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEWAY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEWORKS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 10 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SURGICAL INSTRUMENT MANUFACTURERS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SYNTHES USA PRODUCTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TITAN SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WENZEL SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
XENCO MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZAVATION, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET SPINE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER SPINE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 607 |
Adverse Event Without Identified Device Or Use Problem | 252 |
Migration Or Expulsion Of Device | 213 |
Fracture | 182 |
Mechanical Problem | 105 |
Device Operates Differently Than Expected | 75 |
Material Integrity Problem | 61 |
Migration | 59 |
Mechanical Jam | 59 |
Fitting Problem | 52 |
Unintended Movement | 45 |
Device Dislodged Or Dislocated | 40 |
Malposition Of Device | 33 |
Device-Device Incompatibility | 31 |
Material Deformation | 27 |
Material Fragmentation | 23 |
Loose Or Intermittent Connection | 23 |
Collapse | 22 |
Spacer | 20 |
Difficult To Remove | 18 |
Crack | 16 |
Separation Failure | 15 |
Detachment Of Device Component | 12 |
Insufficient Information | 12 |
Difficult To Insert | 12 |
Material Disintegration | 12 |
Improper Or Incorrect Procedure Or Method | 12 |
Appropriate Term/Code Not Available | 12 |
Detachment Of Device Or Device Component | 11 |
Disassembly | 10 |
Sticking | 9 |
Leak / Splash | 8 |
Activation Failure Including Expansion Failures | 8 |
Failure To Adhere Or Bond | 8 |
Bent | 7 |
Use Of Device Problem | 7 |
Screw | 7 |
No Apparent Adverse Event | 7 |
Device Issue | 7 |
Device Slipped | 7 |
Positioning Problem | 7 |
Failure To Align | 5 |
Device Handling Problem | 5 |
Device Operational Issue | 5 |
Material Twisted / Bent | 5 |
Patient-Device Incompatibility | 5 |
Human Factors Issue | 4 |
Off-Label Use | 4 |
Inadequacy Of Device Shape And/or Size | 4 |
Packaging Problem | 3 |
Dull, Blunt | 3 |
Failure To Disconnect | 3 |
Biocompatibility | 3 |
Device Markings / Labelling Problem | 3 |
Activation, Positioning Or Separation Problem | 3 |
Connection Problem | 3 |
Tip | 2 |
Metal Shedding Debris | 2 |
Component Missing | 2 |
Failure To Osseointegrate | 2 |
Material Rupture | 2 |
Disconnection | 2 |
Material Erosion | 2 |
Naturally Worn | 2 |
Labelling, Instructions For Use Or Training Problem | 2 |
Difficult To Position | 2 |
Missing Value Reason | 2 |
Defective Device | 2 |
Loss Of Osseointegration | 2 |
No Pressure | 2 |
Pressure Problem | 2 |
Material Separation | 2 |
Positioning Failure | 2 |
Material Protrusion / Extrusion | 2 |
Material Torqued | 2 |
Patient Data Problem | 1 |
Installation-Related Problem | 1 |
Tube | 1 |
Plate | 1 |
Ring | 1 |
Component Or Accessory Incompatibility | 1 |
Device Damaged By Another Device | 1 |
Expulsion | 1 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Optical Problem | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Poor Quality Image | 1 |
Peeled / Delaminated | 1 |
Display Or Visual Feedback Problem | 1 |
Device Expiration Issue | 1 |
Torn Material | 1 |
Thread | 1 |
Split | 1 |
Cut In Material | 1 |
Connector | 1 |
Housing | 1 |
Rod | 1 |
Component Falling | 1 |
Material Distortion | 1 |
Corroded | 1 |
| Total Device Problems | 2274 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 4-Web Inc. | II | Dec-16-2014 |
| 2 | Amendia, Inc | II | Dec-20-2016 |
| 3 | Biomet Spine LLC. | II | Dec-16-2014 |
| 4 | Biomet Spine, LLC | II | Feb-09-2015 |
| 5 | DePuy Orthopaedics, Inc. | II | Mar-02-2018 |
| 6 | Howmedica Osteonics Corp. | II | Dec-13-2018 |
| 7 | Howmedica Osteonics Corp. | II | Sep-12-2016 |
| 8 | Integrity Implants Inc. | II | Nov-07-2018 |
| 9 | Interventional Spine Inc | II | Jan-03-2017 |
| 10 | Kiscomedica S.A. | II | Feb-27-2017 |
| 11 | Medacta Usa | II | Nov-18-2014 |
| 12 | Neuropro Spinal Jaxx | II | Apr-10-2018 |
| 13 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | II | Jun-26-2015 |
| 14 | Spinal Elements | II | May-23-2018 |
| 15 | Spinal Elements, Inc | II | Jan-05-2015 |
| 16 | SpineFrontier, Inc. | II | May-07-2014 |
| 17 | Stryker Spine | II | Oct-10-2018 |
| 18 | Stryker Spine | II | Feb-23-2016 |
| 19 | Synthes (USA) Products LLC | II | Apr-14-2016 |
| 20 | X Spine Systems Inc | II | Oct-18-2016 |
| 21 | XTANT MEDICAL INC | II | Jan-30-2019 |
| 22 | Zimmer Biomet Spine, Inc | II | Mar-28-2017 |
| 23 | Zimmer Biomet Spine, Inc | II | Aug-11-2016 |
| 24 | Zimmer Trabecular Metal Technology, Inc. | III | May-10-2017 |