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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, cement restrictor
Regulation Description Surgical mesh.
Product CodeJDK
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPULSE ORTHOPEDICS, INC.
  SE - WITH LIMITATIONS 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SE - WITH LIMITATIONS 1
INTERPORE CROSS
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SE - WITH LIMITATIONS 1
LIFE SPINE
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SE - WITH LIMITATIONS 7
NUVASIVE
  SE - WITH LIMITATIONS 1
OSTEOBIOLOGICS, INC.
  SE - WITH LIMITATIONS 1
OSTEOIMPLANT TECHNOLOGIES
  SE - WITH LIMITATIONS 1
SPINAL CONCEPTS
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 3
SPINEOLOGY INC.
  SE - WITH LIMITATIONS 1
SULZER
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE
  SE - WITH LIMITATIONS 2

Device Problems
No Information 5
Break 2
Device remains implanted 2
Unknown (for use when the device problem is not known) 2
Dislodged or dislocated 1
Foreign material 1
Loose or intermittent connection 1
Total Device Problems 14

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 1 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Depuy Orthopaedics, Inc. II Mar-17-2011
2 Encore Medical, Lp II Jan-09-2008

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