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TPLC - Total Product Life Cycle

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Device intervertebral fusion device with bone graft, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeMAX
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
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 5
ALPHATEC HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 3
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 3
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
DIFUSION TECHNOLOGIES
  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 7
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 5
INTEGRITY IMPLANTS INC
  SUBSTANTIALLY EQUIVALENT 2
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 2
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 9
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DESIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 5
MEDITECH SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 13
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 16
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 3
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NLT SPINE LTD
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 21
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
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
SINTEA PLUSTEK
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  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 11
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
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 755
Adverse Event Without Identified Device or Use Problem 315
Migration or Expulsion of Device 230
Fracture 200
Migration 144
Mechanical Problem 110
Material Integrity Problem 86
Device-Device Incompatibility 82
Device Operates Differently Than Expected 75
Mechanical Jam 68
Collapse 59
Fitting Problem 52
Unintended Movement 50
Device Dislodged or Dislocated 43
Malposition of device 37
Material Deformation 32
Material Fragmentation 29
Detachment of Device or device Component 26
Loose or Intermittent Connection 23
Crack 22
Insufficient Information 21
Spacer 20
Difficult to Remove 20
No Apparent Adverse Event 20
Appropriate Term/Code Not Available 17
Improper or Incorrect Procedure or Method 16
Separation Failure 15
Difficult to Insert 12
Material Disintegration 12
Detachment Of Device Component 12
Use of Device Problem 11
Disassembly 10
Device Handling Problem 9
Sticking 9
Activation Failure Including Expansion Failures 8
Failure To Adhere Or Bond 8
Material Twisted / Bent 8
Leak / Splash 8
Device Slipped 7
Device Issue 7
Bent 7
Positioning Problem 7
Screw 7
Inadequacy of Device Shape and/or Size 6
Material Separation 5
Device Operational Issue 5
Off-Label Use 5
Failure to Align 5
Patient-Device Incompatibility 5
Physical Resistance / Sticking 5
Device Markings / Labelling Problem 4
Device Difficult to Maintain 4
Human Factors Issue 4
Failure to Disconnect 3
Dull, Blunt 3
Loss of Osseointegration 3
Packaging Problem 3
Failure to Osseointegrate 3
Loosening of Implant Not Related to Bone-Ingrowth 3
Material Erosion 3
Biocompatibility 3
Connection Problem 3
Activation, Positioning or Separation Problem 3
Disconnection 3
Labelling, Instructions for Use or Training Problem 2
Unstable 2
Naturally Worn 2
Positioning Failure 2
Material Split, Cut or Torn 2
Material Protrusion / Extrusion 2
Material Torqued 2
Pressure Problem 2
Component Missing 2
Difficult To Position 2
Tip 2
Missing Value Reason 2
Defective Device 2
Device Damaged by Another Device 2
Installation-Related Problem 2
Metal Shedding Debris 2
No Pressure 2
Material Rupture 2
Expulsion 2
Deformation Due to Compressive Stress 1
Partial Blockage 1
Device Expiration Issue 1
Misconnection 1
Driver 1
Torn Material 1
Housing 1
Ring 1
Connector 1
Physical Property Issue 1
Split 1
Tube 1
Misassembled 1
Peeled / Delaminated 1
Cut In Material 1
Failure to Advance 1
Component or Accessory Incompatibility 1
Total Device Problems 2845

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 DePuy Spine, Inc. II Apr-27-2019
7 Howmedica Osteonics Corp. II Dec-13-2018
8 Howmedica Osteonics Corp. II Sep-12-2016
9 Integrity Implants Inc. II Nov-07-2018
10 Interventional Spine Inc II Jan-03-2017
11 Kiscomedica S.A. II Feb-27-2017
12 Medacta Usa II Nov-18-2014
13 Neuropro Spinal Jaxx II Apr-10-2018
14 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jun-26-2015
15 SPINEART SA III Nov-22-2019
16 Spinal Elements II May-23-2018
17 Spinal Elements, Inc II Jan-05-2015
18 SpineFrontier, Inc. II May-07-2014
19 Stryker Spine II Oct-10-2018
20 Stryker Spine II Feb-23-2016
21 Synthes (USA) Products LLC II Apr-14-2016
22 X Spine Systems Inc II Oct-18-2016
23 XTANT MEDICAL INC II Jan-30-2019
24 Zimmer Biomet Spine, Inc II Mar-28-2017
25 Zimmer Biomet Spine, Inc II Aug-11-2016
26 Zimmer Trabecular Metal Technology, Inc. III May-10-2017

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