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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, toe, hemi-, phalangeal
Regulation Description Toe joint phalangeal (hemi-toe) polymer prosthesis.
Product CodeKWD
Regulation Number 888.3730
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 3
DOW
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 3
No Information 2
Unknown (for use when the device problem is not known) 2
Dull 1
Device expiration issue 1
Improper or incorrect procedure or method 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Dec-16-2014
2 OrthoPro LLC II Sep-18-2008

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