• 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, 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
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
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 57
No Known Device Problem 35
Failure to Adhere or Bond 14
Fracture 14
Break 10
Naturally worn 10
No code available 10
Migration of device or device component 8
Fitting problem 8
Unknown (for use when the device problem is not known) 8
Difficult to insert 6
Foreign material present in device 6
Dislodged or dislocated 5
Explanted 4
Loose or intermittent connection 4
Detachment of device component 4
Component missing 4
Device remains implanted 3
Degraded 3
Device expiration issue 3
Loss of or failure to bond 3
Loose 3
Material integrity issue 3
Device-device incompatibility 2
Device operates differently than expected 2
Packaging issue 2
Slippage of device or device component 2
Device damaged prior to use 2
Patient-device incompatibility 2
Implant, removal of 2
Tear, rip or hole in device packaging 2
Loss of osseointegration 2
Malposition of device 1
Delamination 1
Incomplete or missing packaging 1
Other (for use when an appropriate device code cannot be identified) 1
Improper or incorrect procedure or method 1
Size incorrect for patient 1
Device abrasion from instrument or another object 1
Misconnection 1
Mislabeled 1
Delivered as unsterile product 1
Component(s), broken 1
Component(s), worn 1
Crack 1
Osseointegration issue 1
Device packaging compromised 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Total Device Problems 260

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

-
-