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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Description Ankle joint metal/polymer semi-constrained cemented prosthesis.
Product CodeHSN
Regulation Number 888.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 5
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 11
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 147
Naturally worn 77
Loose 72
No Information 51
No Known Device Problem 47
Component(s), worn 41
Unknown (for use when the device problem is not known) 38
Loss of osseointegration 34
Loose or intermittent connection 24
Migration of device or device component 22
Loss of or failure to bond 20
Other (for use when an appropriate device code cannot be identified) 14
Break 9
No code available 9
Malposition of device 6
Size incorrect for patient 3
Electro-magnetic interference (EMI) 2
Component(s), broken 2
Noise, Audible 2
Metal shedding debris 2
Device operates differently than expected 2
Fracture 2
Failure to Adhere or Bond 1
Unstable 1
Improper or incorrect procedure or method 1
Disassembly 1
Premature explantation 1
Device Difficult to Setup or Prepare 1
Dislodged or dislocated 1
Not Applicable 1
Slippage of device or device component 1
Mechanics altered 1
Positioning Issue 1
Device remains implanted 1
Mechanical jam 1
Unintended movement 1
Total Device Problems 640

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

Recalls
Manufacturer Recall Class Date Posted
1 Tornier, Inc II Aug-26-2015
2 Zimmer, Inc. II Dec-10-2013

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