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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product CodeHSX
Regulation Number 888.3520
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 8
DEPUY INTL., LTD.
  2
  SUBSTANTIALLY EQUIVALENT 3
DOW
  1
  SUBSTANTIALLY EQUIVALENT 3
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 9
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SULZER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
No Information 16
No code available 8
Unknown (for use when the device problem is not known) 8
Fitting problem 8
Naturally worn 8
No Known Device Problem 7
Failure to Adhere or Bond 7
Fracture 7
Difficult to insert 6
Break 6
Foreign material present in device 6
Explanted 4
Loose or intermittent connection 4
Migration of device or device component 4
Device remains implanted 3
Loose 3
Device expiration issue 3
Detachment of device component 3
Dislodged or dislocated 3
Material integrity issue 2
Patient-device incompatibility 2
Implant, removal of 2
Tear, rip or hole in device packaging 2
Device damaged prior to use 2
Component missing 2
Loss of or failure to bond 2
Slippage of device or device component 2
Delivered as unsterile product 1
Component(s), broken 1
Component(s), worn 1
Degraded 1
Incomplete or missing packaging 1
Loss of osseointegration 1
Other (for use when an appropriate device code cannot be identified) 1
Delamination 1
Device operates differently than expected 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Total Device Problems 141

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 3 1 0 0 1 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Blue Belt Technologies MN II Jun-27-2014
2 Conformis Inc II Jul-15-2009
3 Smith & Nephew Inc II Mar-03-2010
4 Stelkast Co II Nov-20-2009
5 Zimmer Biomet, Inc. II Feb-22-2016
6 Zimmer Inc. II Dec-22-2009
7 Zimmer, Inc. II Oct-25-2013

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