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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
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
Break 105
No Known Device Problem 78
Mechanical issue 73
Implant, removal of 33
Fracture 32
No Information 22
Component(s), broken 17
Difficult to remove 16
Device operates differently than expected 16
Migration of device or device component 15
Fitting problem 15
Device remains implanted 14
Other (for use when an appropriate device code cannot be identified) 14
Unintended movement 9
Unknown (for use when the device problem is not known) 9
Material deformation 8
Loose 6
Loose or intermittent connection 6
Sticking 5
Displacement 4
Malfunction 4
Particulates 3
Metal shedding debris 3
No code available 3
Bent 3
Material integrity issue 3
Failure to Adhere or Bond 2
Dislodged or dislocated 2
Use of Device Issue 2
Disassembly 2
Material Distortion 2
Dull 2
Slippage of device or device component 2
Device expiration issue 2
Failure to align 2
Blockage within device or device component 2
Detachment of device component 2
Peeled 2
Component incompatible 2
Mechanical jam 2
Material fragmentation 1
Material separation 1
Device Issue 1
Material torqued 1
Size incorrect for patient 1
Device-device incompatibility 1
Foreign material present in device 1
Misplacement 1
Detachment of device or device component 1
Naturally worn 1
Crack 1
Mechanics altered 1
Positioning Issue 1
Difficult to advance 1
Device abrasion from instrument or another object 1
Mislabeled 1
Component missing 1
Difficult to open or close 1
Interlock(s), failure of 1
Corrosion 1
Improper or incorrect procedure or method 1
Tear, rip or hole in device packaging 1
Failure to advance 1
Human-Device Interface Issue 1
Foreign material 1
Device, or device fragments remain in patient 1
Total Device Problems 570

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 2
Class III 0 0 0 0 0 0 0 0 0 0

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

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