• 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 Known Device Problem 32
No Information 31
Failure to Adhere or Bond 12
Break 9
Fracture 9
No code available 9
Naturally worn 9
Unknown (for use when the device problem is not known) 8
Fitting problem 8
Difficult to insert 6
Foreign material present in device 6
Loose or intermittent connection 4
Migration of device or device component 4
Explanted 4
Dislodged or dislocated 4
Device remains implanted 3
Loose 3
Detachment of device component 3
Device expiration issue 3
Material integrity issue 3
Degraded 2
Loss of or failure to bond 2
Slippage of device or device component 2
Patient-device incompatibility 2
Device damaged prior to use 2
Component missing 2
Implant, removal of 2
Tear, rip or hole in device packaging 2
Loss of osseointegration 1
Malposition of device 1
Incomplete or missing packaging 1
Delamination 1
Device operates differently than expected 1
Device packaging compromised 1
Other (for use when an appropriate device code cannot be identified) 1
Improper or incorrect procedure or method 1
Mislabeled 1
Delivered as unsterile product 1
Device abrasion from instrument or another object 1
Component(s), broken 1
Component(s), worn 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Total Device Problems 201

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

-
-