Intervertebral Fusion Device With Bone Graft, Lumbar

Device Code: 4612

Product Code(s): MAX

Definition: Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.

Device Classification Information

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

Recognized Standards

11-185 ASTM F2267-04 (Reapproved 2018)
Standard Test Method For Measuring Load Induced Subsidence Of Intervertebral Body Fusion Device Under Static Axial Compression
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice For Permanent Marking Of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice For Care And Handling Of Orthopedic Implants And Instruments
11-288 ASTM F2077-14
Test Methods For Intervertebral Body Fusion Devices
11-331 ASTM F2077-17
Test Methods For Intervertebral Body Fusion Devices
11-347 ASTM F2077-18
Test Methods For Intervertebral Body Fusion Devices

Total Product Life Cycle

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

TPLC Last Update: 2019-04-02 20:52:46