• 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 appliance, fixation, nail/blade/plate combination, multiple component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 9
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 9
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 36
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HAND INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MILLENNIUM
  SUBSTANTIALLY EQUIVALENT 1
NEWMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 7
PFIZER
  SUBSTANTIALLY EQUIVALENT 3
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
STERILMED
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 28
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 32
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 10
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
No Known Device Problem 173
Break 166
Mechanical issue 104
Fracture 38
Implant, removal of 33
No Information 29
Device operates differently than expected 26
Migration of device or device component 26
Fitting problem 24
Difficult to remove 19
Unintended movement 18
Component(s), broken 17
Device remains implanted 14
Other (for use when an appropriate device code cannot be identified) 14
Unknown (for use when the device problem is not known) 9
Material deformation 8
Bent 7
Loose or intermittent connection 7
Loose 6
Sticking 5
Dislodged or dislocated 5
Failure to align 5
Malfunction 4
Mechanical jam 4
Failure to Adhere or Bond 4
Material fragmentation 4
Displacement 4
Corrosion 3
Use of Device Issue 3
Metal shedding debris 3
Particulates 3
No code available 3
Material integrity issue 3
Dull 3
Component missing 2
Material Distortion 2
Detachment of device or device component 2
Peeled 2
Slippage of device or device component 2
Crack 2
Disassembly 2
Blockage within device or device component 2
Detachment of device component 2
Component incompatible 2
Device expiration issue 2
Explanted 1
Foreign material 1
Material separation 1
Size incorrect for patient 1
Improper or incorrect procedure or method 1
Interlock(s), failure of 1
Device, or device fragments remain in patient 1
Mislabeled 1
Misplacement 1
Device abrasion from instrument or another object 1
Mechanics altered 1
Naturally worn 1
Positioning Issue 1
Material torqued 1
Foreign material present in device 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Device Issue 1
Tear, rip or hole in device packaging 1
Failure to advance 1
Malposition of device 1
Patient-device incompatibility 1
Device-device incompatibility 1
Difficult to advance 1
Difficult to open or close 1
Total Device Problems 841

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 1 2 3 0 1 3 6 3 2 5 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Jun-09-2015
3 Biomet, Inc. II Dec-17-2012
4 Depuy Orthopaedics, Inc. II Jan-24-2008
5 Integra LifeSciences Corp. II Aug-11-2016
6 Integra LifeSciences Corp. II Jul-27-2016
7 Kinamed Inc II Jun-17-2011
8 Plus Orthopedics USA II Dec-08-2007
9 Small Bone Innovations, Inc. II Jun-04-2014
10 Sterilmed Inc II Jan-13-2009
11 Stryker Howmedica Osteonics Corp. II Jan-17-2013
12 Stryker Howmedica Osteonics Corp. II Nov-08-2012
13 Stryker Howmedica Osteonics Corp. II Aug-18-2009
14 Stryker Howmedica Osteonics Corp. II Sep-16-2008
15 Synthes (USA) Products LLC II Aug-24-2015
16 Synthes Spine II May-29-2009
17 Synthes USA HQ, Inc. II Dec-10-2013
18 Synthes USA HQ, Inc. II Nov-27-2013
19 Synthes USA HQ, Inc. II Sep-25-2013
20 Synthes USA HQ, Inc. II Mar-11-2013
21 Synthes USA HQ, Inc. II Nov-13-2012
22 Synthes, Inc. II Jun-19-2014
23 Zimmer Manufacturing B.V. II May-16-2016
24 Zimmer Manufacturing B.V. II Mar-12-2016
25 Zimmer, Inc. II Feb-20-2014
26 Zimmer, Inc. II Aug-26-2013

-
-