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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, nail/blade/plate combination, single component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTW
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  1
  SUBSTANTIALLY EQUIVALENT 7
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 22
Break 15
Migration of device or device component 8
Component(s), broken 3
Implant, removal of 3
No Information 3
Device remains implanted 2
Tip breakage 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Device operates differently than expected 1
Dislodged or dislocated 1
Unintended movement 1
Total Device Problems 62

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon Endo-Surgery Inc II Nov-02-2010
2 Synthes USA (HQ), Inc. II Feb-16-2011

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