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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filler, bone void, osteoinduction (w/o human growth factor)
Regulation Description Resorbable calcium salt bone void filler device.
Product CodeMBP
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
BACTERIN INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
ISOTIS ORTHOBIOLOGICS, INC
  SUBSTANTIALLY EQUIVALENT 3
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIFENET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 7
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
REGENERATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 5
Extrusion 1
Use of Device Issue 1
Inaudible voice prompts 1
User used incorrect product for intended use 1
No Information 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Bacterin International, Inc. II Apr-17-2013
2 Bacterin International, Inc. II Feb-11-2013
3 Integra LifeSciences Corp. II Jun-25-2014
4 Medtronic Sofamor Danek USA Inc II Feb-12-2014
5 Osteotech Inc II Oct-18-2012
6 Osteotech Inc II Jan-11-2012

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