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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 196
No Known Device Problem 70
Material fragmentation 33
Fracture 31
Device operates differently than expected 31
Migration of device or device component 27
No Information 21
Loose or intermittent connection 17
Detachment of device or device component 10
Device-device incompatibility 10
Difficult to insert 9
Failure to Adhere or Bond 8
Unintended movement 8
Metal shedding debris 7
Malposition of device 6
No code available 6
Size incorrect for patient 5
Bent 5
Detachment of device component 4
Device expiration issue 4
Fitting problem 4
Material deformation 4
Dislodged or dislocated 3
Difficult to remove 3
Device or device fragments location unknown 3
Connection issue 2
Device Issue 2
Device inoperable 2
Instruction for use issue 2
Manufacturing or shipping issue associated with device 2
Material Protrusion 2
Not Applicable 2
Positioning Issue 1
Device or device component damaged by another device 1
Particulates 1
Peeled 1
Performance 1
Device, or device fragments remain in patient 1
Explanted 1
Difficult to deploy 1
Component(s), broken 1
Use of Device Issue 1
Implant, removal of 1
Material separation 1
Slippage of device or device component 1
Dull 1
Malfunction 1
Failure to align 1
Patient-device incompatibility 1
Component or accessory incompatibility 1
Total Device Problems 557

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 1
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 Jun-07-2016
12 Synthes (USA) Products LLC II Jul-28-2015
13 Synthes USA (HQ), Inc. II Oct-26-2009
14 Synthes USA HQ, Inc. II Mar-12-2013
15 Walter Lorenz Surgical, Inc. II Jan-11-2012

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