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U.S. Department of Health and Human Services

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
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 12
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERVENTIONAL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
K2M
  SUBSTANTIALLY EQUIVALENT 2
LANX
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 36
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 5
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 4
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 2
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 5
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 11
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 5
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 16
SPINEVISION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 18
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 2
TRANS1
  SUBSTANTIALLY EQUIVALENT 3
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 402
Migration of device or device component 183
No Known Device Problem 130
Fracture 117
Mechanical issue 85
Fitting problem 48
Device operates differently than expected 40
Dislodged or dislocated 36
Material integrity issue 36
Unintended movement 30
Mechanical jam 26
Malposition of device 26
Loose or intermittent connection 25
Collapse 19
Crack 16
Detachment of device component 15
Material fragmentation 15
Difficult to remove 13
Implant, repositioning of 12
Material deformation 12
Failure to separate 11
No code available 10
Improper or incorrect procedure or method 9
Failure to Adhere or Bond 9
Bent 9
Leak 8
Slippage of device or device component 8
Sticking 8
Connection issue 8
Detachment of device or device component 8
Explanted 7
Failure to expand 7
No Information 6
Difficult to insert 6
Device remains implanted 6
Disassembly 6
Implant breakage or physical damage 6
Failure to align 6
Implant, removal of 5
Not Applicable 5
Positioning Issue 5
Use of Device Issue 4
Size incorrect for patient 4
Disconnection 4
Material disintegration 4
Device, or device fragments remain in patient 4
Difficult to position 3
User used incorrect product for intended use 3
Dull 3
Device Issue 3
Patient-device incompatibility 3
Biocompatibility issue 2
Device markings issue 2
Failure to osseointegrate 2
Material rupture 2
Difficult to deploy 2
Failure to deploy 2
Material erosion 2
Device expiration issue 2
Pressure issue 2
Material twisted 2
Packaging issue 2
No Pressure 2
Material Protrusion 2
Material torqued 1
Material Distortion 1
Expulsion 1
Installation-related problem 1
Device or device component damaged by another device 1
Device sensing issue 1
Optical issue 1
Naturally worn 1
Device Difficult to maintain 1
Patient Data Issue 1
Device handling issue 1
Incorrect display 1
Failure to capture 1
Component falling 1
Intermittent continuity 1
Failure to power-up 1
Misconnection 1
Normal 1
Peeled 1
Accessory incompatible 1
Loose 1
Material separation 1
Metal shedding debris 1
Loss of osseointegration 1
Malfunction 1
Dissatisfaction 1
Cut in material 1
Device misassembled during manufacturing or shipping 1
Deployment issue 1
Disinfection or Sterilization Issue at User Location 1
Internal fixation, revision of 1
Defective item 1
Locking mechanism failure 1
Failure to advance 1
Split 1
Failure to disconnect 1
Total Device Problems 1536

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 1 0 0 0 0 0
Class II 0 1 3 0 1 5 8 4 3 6 3
Class III 0 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 4-Web Inc. II Dec-16-2014
2 Aesculap, Inc. II Jul-25-2013
3 Alphatec Spine, Inc. II May-29-2012
4 Alphatec Spine, Inc. II Nov-12-2009
5 Amendia, Inc II Dec-20-2016
6 Biomet Spine LLC. II Dec-16-2014
7 Biomet Spine, LLC II Feb-09-2015
8 Captiva Spine, Inc II Jun-07-2012
9 Ebi, Llc II Sep-27-2013
10 Genesys Orthopedic Systems, LLC II Jun-01-2012
11 Howmedica Osteonics Corp. II Sep-12-2016
12 Interventional Spine Inc II Jan-03-2017
13 Kiscomedica S.A. II Feb-27-2017
14 Medacta Usa II Nov-18-2014
15 Medtronic Sofamor Danek USA Inc II Jul-24-2009
16 Orthofix, Inc. II Feb-15-2012
17 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jun-26-2015
18 Spinal Elements, Inc II Jan-05-2015
19 Spinal Solutions, LLC II May-27-2013
20 Spinal Solutions, LLC II Apr-22-2013
21 Spine Smith Holdings, LLC II Sep-19-2013
22 Spine Smith Partners LP II Mar-10-2013
23 Spine Wave, Inc. II Sep-11-2013
24 SpineFrontier, Inc. II May-07-2014
25 SpineFrontier, Inc. II Nov-21-2012
26 Stryker Spine II Feb-23-2016
27 Stryker Spine II Oct-20-2008
28 Synthes (USA) Products LLC II Apr-14-2016
29 Synthes Spine II Jan-30-2009
30 Synthes USA (HQ), Inc. II Nov-04-2011
31 X Spine Systems Inc II Oct-18-2016
32 Zimmer Biomet Spine, Inc II Mar-28-2017
33 Zimmer Biomet Spine, Inc II Aug-11-2016
34 Zimmer Trabecular Metal Technology, Inc. III May-10-2017
35 Zimmer, Inc. II Jan-09-2013
36 Zimmer, Inc. I Dec-22-2012

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