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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 1
LANX
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 34
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 10
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 5
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 15
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 342
Migration of device or device component 151
Fracture 102
No Known Device Problem 87
Mechanical issue 74
Fitting problem 43
Device operates differently than expected 39
Dislodged or dislocated 33
Material integrity issue 29
Loose or intermittent connection 23
Malposition of device 22
Mechanical jam 22
Unintended movement 16
Collapse 16
Crack 15
Difficult to remove 13
Implant, repositioning of 12
Material fragmentation 12
Detachment of device component 11
Material deformation 11
Bent 10
Failure to Adhere or Bond 9
Improper or incorrect procedure or method 9
Detachment of device or device component 8
Failure to separate 8
Leak 8
Explanted 7
Connection issue 7
Sticking 7
Failure to expand 7
Not Applicable 6
No Information 6
No code available 6
Implant breakage or physical damage 6
Failure to align 6
Device remains implanted 6
Difficult to insert 5
Disassembly 5
Slippage of device or device component 5
Implant, removal of 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 2
Material rupture 2
Failure to advance 2
Patient-device incompatibility 2
Biocompatibility issue 2
Device markings issue 2
Device expiration issue 2
Failure to deploy 2
Pressure issue 2
No Pressure 2
Material twisted 2
Material Protrusion 2
Packaging issue 2
Device Difficult to maintain 1
Material torqued 1
Expulsion 1
Naturally worn 1
Optical issue 1
Patient Data Issue 1
Device handling issue 1
Difficult to deploy 1
Incorrect display 1
Accessory incompatible 1
Failure to capture 1
Component falling 1
Intermittent continuity 1
Loose 1
Failure to power-up 1
Misconnection 1
Normal 1
Peeled 1
Device misassembled during manufacturing or shipping 1
Device or device component damaged by another device 1
Device sensing issue 1
Deployment issue 1
Defective item 1
Locking mechanism failure 1
Disinfection or Sterilization Issue at User Location 1
Split 1
Failure to disconnect 1
Material separation 1
Metal shedding debris 1
Internal fixation, revision of 1
Loss of osseointegration 1
Malfunction 1
Dissatisfaction 1
Cut in material 1
Total Device Problems 1303

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 1
Class III 0 0 0 0 0 0 0 0 0 0 0

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 Medacta Usa II Nov-18-2014
14 Medtronic Sofamor Danek USA Inc II Jul-24-2009
15 Orthofix, Inc. II Feb-15-2012
16 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jun-26-2015
17 Spinal Elements, Inc II Jan-05-2015
18 Spinal Solutions, LLC II May-27-2013
19 Spinal Solutions, LLC II Apr-22-2013
20 Spine Smith Holdings, LLC II Sep-19-2013
21 Spine Smith Partners LP II Mar-10-2013
22 Spine Wave, Inc. II Sep-11-2013
23 SpineFrontier, Inc. II May-07-2014
24 SpineFrontier, Inc. II Nov-21-2012
25 Stryker Spine II Feb-23-2016
26 Stryker Spine II Oct-20-2008
27 Synthes (USA) Products LLC II Apr-14-2016
28 Synthes Spine II Jan-30-2009
29 Synthes USA (HQ), Inc. II Nov-04-2011
30 X Spine Systems Inc II Oct-18-2016
31 Zimmer Biomet Spine, Inc II Aug-11-2016
32 Zimmer, Inc. II Jan-09-2013
33 Zimmer, Inc. I Dec-22-2012

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