TPLC - Total Product Life Cycle

• 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 Code: LYC
• Regulation Number: 872.3930
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	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	5
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	4
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
Device remains implanted	2
Other (for use when an appropriate device code cannot be identified)	2
Unknown (for use when the device problem is not known)	1
Implant, removal of	1
Dissatisfaction	1
Loss of or failure to bond	1
Total Device Problems	8

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	1	1	0	2	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Ace Surgical Supply Co., Inc.	II	Jun-16-2010
2	Cytophil, Inc	II	Feb-13-2012
3	Integra LifeSciences Corporation	II	May-10-2013
4	Kerr Corporation	II	Nov-20-2012
5	Zimmer Inc.	II	Feb-06-2009