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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, bone
Regulation Description Bone plate.
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
AZARY TECHNOLOGIES LLC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 11
BIONX
  SUBSTANTIALLY EQUIVALENT 7
BIOPLATE, INC.
  SUBSTANTIALLY EQUIVALENT 16
CEREMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INION
  SUBSTANTIALLY EQUIVALENT 7
KARL LEIBINGER GMBH U. CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 12
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MONDEAL MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 7
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 14
SYNTHES
  SUBSTANTIALLY EQUIVALENT 42
TI-MESH, INC.
  SUBSTANTIALLY EQUIVALENT 2
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
Break 172
No Known Device Problem 52
Device operates differently than expected 31
Fracture 25
Material fragmentation 23
No Information 18
Migration of device or device component 18
Loose or intermittent connection 16
Device-device incompatibility 10
Difficult to insert 9
Detachment of device or device component 9
Failure to Adhere or Bond 8
Metal shedding debris 7
No code available 6
Malposition of device 6
Unintended movement 6
Size incorrect for patient 5
Bent 5
Detachment of device component 4
Device expiration issue 4
Device or device fragments location unknown 3
Material deformation 3
Difficult to remove 3
Dislodged or dislocated 3
Not Applicable 2
Connection issue 2
Fitting problem 2
Material Protrusion 2
Instruction for use issue 2
Slippage of device or device component 1
Implant, removal of 1
Failure to align 1
Component(s), broken 1
Manufacturing or shipping issue associated with device 1
Positioning Issue 1
Dull 1
Malfunction 1
Material separation 1
Device Issue 1
Component or accessory incompatibility 1
Device or device component damaged by another device 1
Peeled 1
Difficult to deploy 1
Explanted 1
Particulates 1
Use of Device Issue 1
Device, or device fragments remain in patient 1
Performance 1
Total Device Problems 475

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 0 3 1 2 2 2 1 0 1 0
Class III 0 0 0 2 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bioplate Inc II Nov-01-2011
2 Biomet Microfixation, Inc. II May-27-2011
3 Biomet Microfixation, Inc. II Oct-20-2010
4 Biomet Microfixation, Inc. III Jun-30-2010
5 Biomet Microfixation, Inc. III Mar-17-2010
6 Biomet Microfixation, Inc. II Nov-04-2008
7 Biomet Microfixation, Inc. II Sep-16-2008
8 Biomet Microfixation, LLC II Mar-23-2012
9 Stryker Craniomaxillofacial Division II Dec-16-2010
10 Stryker Leibinger USA II Dec-30-2008
11 Synthes (USA) Products LLC II Jul-28-2015
12 Synthes USA (HQ), Inc. II Oct-26-2009
13 Synthes USA HQ, Inc. II Mar-12-2013
14 Walter Lorenz Surgical, Inc. II Jan-11-2012

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