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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 80
No Information 79
Loose 72
No Known Device Problem 48
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
No code available 11
Break 10
Failure to Adhere or Bond 6
Malposition of device 6
Device operates differently than expected 4
Fracture 3
Size incorrect for patient 3
Disassembly 3
Electro-magnetic interference (EMI) 2
Component(s), broken 2
Metal shedding debris 2
Noise, Audible 2
Positioning Issue 1
Unintended movement 1
Not Applicable 1
Dislodged or dislocated 1
Mechanical jam 1
Mechanics altered 1
Detachment of device or device component 1
Improper or incorrect procedure or method 1
Slippage of device or device component 1
Unstable 1
Premature explantation 1
Device Difficult to Setup or Prepare 1
Device remains implanted 1
Total Device Problems 686

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

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Jun-29-2016
2 Tornier, Inc II Aug-26-2015
3 Zimmer, Inc. II Dec-10-2013

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