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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 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 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 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 8
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DESIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
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 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
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 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
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, 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 4
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 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
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 695
Adverse Event Without Identified Device or Use Problem 302
Migration or Expulsion of Device 221
Fracture 192
Migration 117
Mechanical Problem 110
Material Integrity Problem 77
Device Operates Differently Than Expected 75
Mechanical Jam 66
Device-Device Incompatibility 57
Collapse 54
Fitting Problem 52
Unintended Movement 50
Device Dislodged or Dislocated 42
Malposition of device 36
Material Deformation 30
Material Fragmentation 28
Loose or Intermittent Connection 23
Spacer 20
Detachment of Device or device Component 20
Crack 18
Insufficient Information 18
No Apparent Adverse Event 18
Difficult to Remove 18
Appropriate Term/Code Not Available 17
Improper or Incorrect Procedure or Method 16
Separation Failure 15
Detachment Of Device Component 12
Difficult to Insert 12
Material Disintegration 12
Use of Device Problem 11
Disassembly 10
Sticking 9
Device Handling Problem 9
Leak / Splash 8
Activation Failure Including Expansion Failures 8
Failure To Adhere Or Bond 8
Bent 7
Material Twisted / Bent 7
Screw 7
Device Issue 7
Positioning Problem 7
Device Slipped 7
Failure to Align 5
Off-Label Use 5
Material Separation 5
Inadequacy of Device Shape and/or Size 5
Device Operational Issue 5
Patient-Device Incompatibility 5
Device Difficult to Maintain 4
Human Factors Issue 4
Loss of Osseointegration 3
Packaging Problem 3
Dull, Blunt 3
Failure to Disconnect 3
Biocompatibility 3
Device Markings / Labelling Problem 3
Disconnection 3
Material Erosion 3
Connection Problem 3
Activation, Positioning or Separation Problem 3
Failure to Osseointegrate 3
Unstable 2
Metal Shedding Debris 2
Component Missing 2
Material Split, Cut or Torn 2
Tip 2
Material Rupture 2
Naturally Worn 2
Labelling, Instructions for Use or Training Problem 2
Difficult To Position 2
Missing Value Reason 2
Defective Device 2
Pressure Problem 2
No Pressure 2
Installation-Related Problem 2
Material Protrusion / Extrusion 2
Material Torqued 2
Positioning Failure 2
Loosening of Implant Not Related to Bone-Ingrowth 2
Patient Device Interaction Problem 1
Misassembly by Users 1
Patient Data Problem 1
Tube 1
Plate 1
Ring 1
Component or Accessory Incompatibility 1
Device Damaged by Another Device 1
Expulsion 1
Optical Problem 1
Device Misassembled During Manufacturing / Shipping 1
Partial Blockage 1
Poor Quality Image 1
Peeled / Delaminated 1
Separation Problem 1
Display or Visual Feedback Problem 1
Device Expiration Issue 1
Torn Material 1
Thread 1
Split 1
Total Device Problems 2655

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 Spinal Elements II May-23-2018
16 Spinal Elements, Inc II Jan-05-2015
17 SpineFrontier, Inc. II May-07-2014
18 Stryker Spine II Oct-10-2018
19 Stryker Spine II Feb-23-2016
20 Synthes (USA) Products LLC II Apr-14-2016
21 X Spine Systems Inc II Oct-18-2016
22 XTANT MEDICAL INC II Jan-30-2019
23 Zimmer Biomet Spine, Inc II Mar-28-2017
24 Zimmer Biomet Spine, Inc II Aug-11-2016
25 Zimmer Trabecular Metal Technology, Inc. III May-10-2017

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