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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 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 5
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 9
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERVENTIONAL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
LANX
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 4
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 21
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 3
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 7
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 10
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 4
TRANS1
  SUBSTANTIALLY EQUIVALENT 3
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 108
Migration of device or device component 51
Implant, repositioning of 12
No Known Device Problem 10
Explanted 7
Crack 7
Malposition of device 6
Implant breakage or physical damage 6
Connection issue 5
Device remains implanted 5
Implant, removal of 5
Detachment of device component 5
Loose or intermittent connection 5
Device, or device fragments remain in patient 4
Bent 3
Detachment of device or device component 3
Fracture 3
Disconnection 2
Improper or incorrect procedure or method 2
Dislodged or dislocated 2
No Information 1
No code available 1
Fitting problem 1
Sticking 1
Use of Device Issue 1
Device sensing issue 1
Internal fixation, revision of 1
Malfunction 1
Dissatisfaction 1
Failure to align 1
Locking mechanism failure 1
Device expiration issue 1
Loose 1
Normal 1
Intermittent continuity 1
Difficult to deploy 1
Disassembly 1
Failure to capture 1
Accessory incompatible 1
Failure to Adhere or Bond 1
Total Device Problems 271

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 1 0
Class II 0 1 3 0 1 5 3
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II May-29-2012
2 Alphatec Spine, Inc. II Nov-12-2009
3 Captiva Spine, Inc II Jun-07-2012
4 Genesys Orthopedic Systems, LLC II Jun-01-2012
5 Medtronic Sofamor Danek USA Inc II Jul-24-2009
6 Orthofix, Inc. II Feb-15-2012
7 Spinal Solutions, LLC II Apr-22-2013
8 Spine Smith Partners LP II Mar-10-2013
9 SpineFrontier, Inc. II Nov-21-2012
10 Stryker Spine II Oct-20-2008
11 Synthes Spine II Jan-30-2009
12 Synthes USA (HQ), Inc. II Nov-04-2011
13 Zimmer, Inc. II Jan-09-2013
14 Zimmer, Inc. I Dec-22-2012

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