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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone grafting material, synthetic
Regulation Description Bone grafting material.
Definition A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Product CodeLYC
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BICON
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPOSITES LTD.
  SUBSTANTIALLY EQUIVALENT 3
BIOFORM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLOK INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLLA-TEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CYTOPHIL INC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ETEX CORP.
  SUBSTANTIALLY EQUIVALENT 3
HARVEST
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
ISOTIS ORTHOBIOLOGICS, INC
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
LIFECORE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
OSSACUR AG
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Information 95
Osseointegration issue 18
Failure to osseointegrate 12
No Known Device Problem 4
Device operates differently than expected 3
Loss of or failure to bond 2
Other (for use when an appropriate device code cannot be identified) 2
Migration of device or device component 2
Device remains implanted 2
Shelf life exceeded 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Implant, removal of 1
Dissatisfaction 1
Delamination 1
Device expiration issue 1
Not Applicable 1
No code available 1
Total Device Problems 149

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

Recalls
Manufacturer Recall Class Date Posted
1 Ace Surgical Supply Co., Inc. II Jun-16-2010
2 Biomet 3i, LLC III Mar-19-2014
3 Biomet France SARL II Feb-09-2016
4 Cytophil, Inc II Feb-13-2012
5 Integra LifeSciences Corporation II May-10-2013
6 Kerr Corporation II Nov-20-2012
7 Osteogenics Biomedical, Inc. II Oct-18-2016
8 Zimmer Inc. II Feb-06-2009

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