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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 144
Break 121
Mechanical issue 78
Fracture 33
Implant, removal of 33
No Information 24
Device operates differently than expected 18
Component(s), broken 17
Migration of device or device component 17
Fitting problem 17
Difficult to remove 16
Device remains implanted 14
Other (for use when an appropriate device code cannot be identified) 14
Unintended movement 12
Unknown (for use when the device problem is not known) 9
Material deformation 8
Loose or intermittent connection 7
Loose 6
Sticking 5
Displacement 4
Bent 4
Dislodged or dislocated 4
Malfunction 4
Material integrity issue 3
No code available 3
Use of Device Issue 3
Metal shedding debris 3
Particulates 3
Peeled 2
Component missing 2
Blockage within device or device component 2
Crack 2
Disassembly 2
Detachment of device component 2
Component incompatible 2
Device expiration issue 2
Mechanical jam 2
Dull 2
Failure to align 2
Failure to Adhere or Bond 2
Slippage of device or device component 2
Material Distortion 2
Foreign material present in device 1
Human-Device Interface Issue 1
Device-device incompatibility 1
Difficult to advance 1
Difficult to open or close 1
Device Issue 1
Tear, rip or hole in device packaging 1
Failure to advance 1
Detachment of device or device component 1
Positioning Issue 1
Mechanics altered 1
Naturally worn 1
Material torqued 1
Foreign material 1
Material fragmentation 1
Device abrasion from instrument or another object 1
Corrosion 1
Improper or incorrect procedure or method 1
Interlock(s), failure of 1
Mislabeled 1
Misplacement 1
Device, or device fragments remain in patient 1
Material separation 1
Size incorrect for patient 1
Total Device Problems 676

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 1 2 3 0 1 3 6 3 2 3
Class III 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 Kinamed Inc II Jun-17-2011
6 Plus Orthopedics USA II Dec-08-2007
7 Small Bone Innovations, Inc. II Jun-04-2014
8 Sterilmed Inc II Jan-13-2009
9 Stryker Howmedica Osteonics Corp. II Jan-17-2013
10 Stryker Howmedica Osteonics Corp. II Nov-08-2012
11 Stryker Howmedica Osteonics Corp. II Aug-18-2009
12 Stryker Howmedica Osteonics Corp. II Sep-16-2008
13 Synthes (USA) Products LLC II Aug-24-2015
14 Synthes Spine II May-29-2009
15 Synthes USA HQ, Inc. II Dec-10-2013
16 Synthes USA HQ, Inc. II Nov-27-2013
17 Synthes USA HQ, Inc. II Sep-25-2013
18 Synthes USA HQ, Inc. II Mar-11-2013
19 Synthes USA HQ, Inc. II Nov-13-2012
20 Synthes, Inc. II Jun-19-2014
21 Zimmer Manufacturing B.V. II May-16-2016
22 Zimmer Manufacturing B.V. II Mar-12-2016
23 Zimmer, Inc. II Feb-20-2014
24 Zimmer, Inc. II Aug-26-2013

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