• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 14
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 147
No Information 103
Naturally worn 80
No Known Device Problem 75
Loose 72
Component(s), worn 41
Migration of device or device component 40
Unknown (for use when the device problem is not known) 38
Loss of osseointegration 36
Loose or intermittent connection 24
Loss of or failure to bond 20
Break 14
Other (for use when an appropriate device code cannot be identified) 14
No code available 13
Device operates differently than expected 10
Disassembly 10
Failure to Adhere or Bond 8
Malposition of device 8
Device inoperable 4
Difficult to position 3
Fracture 3
Electro-magnetic interference (EMI) 2
Component(s), broken 2
Metal shedding debris 2
Size incorrect for patient 2
Noise, Audible 2
Positioning Issue 1
Unintended movement 1
Not Applicable 1
Detachment of device or device component 1
Dislodged or dislocated 1
Mechanical jam 1
Mechanics altered 1
Improper or incorrect procedure or method 1
Premature explantation 1
Device Difficult to Setup or Prepare 1
Device remains implanted 1
Component incompatible 1
Total Device Problems 785

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Feb-11-2017
2 Integra LifeSciences Corp. II Jun-29-2016
3 Tornier, Inc II Aug-26-2015
4 Zimmer, Inc. II Dec-10-2013

-
-