TPLC - Total Product Life Cycle

• Device: plate, bone
• Regulation Description: Bone plate.
• Product Code: JEY
• Regulation Number: 872.4760
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	2
AZARY TECHNOLOGIES LLC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	7
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	11
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	5
POREX SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROSURG, INC.
	SUBSTANTIALLY EQUIVALENT	2
SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
STRAUMANN
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	10
SYNTHES
	SUBSTANTIALLY EQUIVALENT	42
TI-MESH, INC.
	SUBSTANTIALLY EQUIVALENT	2
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	15

Device Problems
Break	25
No Information	2
No code available	1
Bent	1
Component(s), broken	1
Explanted	1
Migration of device or device component	1
Performance	1
Device, or device fragments remain in patient	1
Fitting problem	1
Implant, removal of	1
Device Issue	1
Malfunction	1
Component or accessory incompatibility	1
Material Protrusion	1
No Known Device Problem	1
Total Device Problems	41

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	3	1	2	2	2	1
Class III	0	0	0	2	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 (HQ), Inc.	II	Oct-26-2009
12	Synthes USA HQ, Inc.	II	Mar-12-2013
13	Walter Lorenz Surgical, Inc.	II	Jan-11-2012