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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 1
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 9
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 3
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
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 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 3
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 13
STERILMED
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 27
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 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Implant, removal of 33
Fracture 24
Component(s), broken 17
No Information 16
Other (for use when an appropriate device code cannot be identified) 14
Device remains implanted 14
Break 11
Unknown (for use when the device problem is not known) 9
Loose 6
Migration of device or device component 6
Displacement 4
Malfunction 4
Disassembly 2
Failure to Adhere or Bond 1
Blockage within device or device component 1
Device expiration issue 1
Foreign material 1
Loose or intermittent connection 1
Mislabeled 1
Misplacement 1
Device abrasion from instrument or another object 1
Device, or device fragments remain in patient 1
Interlock(s), failure of 1
Fitting problem 1
Dislodged or dislocated 1
Foreign material present in device 1
No Known Device Problem 1
Device Issue 1
Total Device Problems 175

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 2 3 0 1 3 2
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2012
2 Depuy Orthopaedics, Inc. II Jan-24-2008
3 Kinamed Inc II Jun-17-2011
4 Plus Orthopedics USA II Dec-08-2007
5 Sterilmed Inc II Jan-13-2009
6 Stryker Howmedica Osteonics Corp. II Jan-17-2013
7 Stryker Howmedica Osteonics Corp. II Nov-08-2012
8 Stryker Howmedica Osteonics Corp. II Aug-18-2009
9 Stryker Howmedica Osteonics Corp. II Sep-16-2008
10 Synthes Spine II May-29-2009
11 Synthes USA HQ, Inc. II Mar-11-2013
12 Synthes USA HQ, Inc. II Nov-13-2012

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