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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, wrist, carpal trapezium
Regulation Description Wrist joint carpal trapezium polymer prosthesis.
Product CodeKYI
Regulation Number 888.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTIMPLANT AB
  SUBSTANTIALLY EQUIVALENT 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
AVANTA
  1
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 1
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Implant, removal of 116
Explanted 39
Unknown (for use when the device problem is not known) 13
Component(s), broken 6
Break 3
Total Device Problems 177

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

Recalls
Manufacturer Recall Class Date Posted
1 Ascension Orthopedics, Inc II Nov-22-2010
2 Integra LifeSciences Corp. III Jun-21-2013

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