TPLC - Total Product Life Cycle

• Device: fastener, fixation, biodegradable, soft tissue
• Regulation Description: Single/multiple component metallic bone fixation appliances and accessories.
• Product Code: MAI
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	21
AXYA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIOMET
	SUBSTANTIALLY EQUIVALENT	4
BIONX
	SUBSTANTIALLY EQUIVALENT	11
CONMED
	SUBSTANTIALLY EQUIVALENT	2
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	14
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
HOGAN & HARTSON L.L.P.
	SUBSTANTIALLY EQUIVALENT	1
INION
	SUBSTANTIALLY EQUIVALENT	2
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
LINVATEC
	SUBSTANTIALLY EQUIVALENT	12
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
MITEK
	SUBSTANTIALLY EQUIVALENT	4
SCANDIUS BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	7
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	3
SYNTHES
	SUBSTANTIALLY EQUIVALENT	2
TORNIER
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1

Device Problems
Break	71
Unknown (for use when the device problem is not known)	64
Tip breakage	35
Material fragmentation	10
Device, or device fragments remain in patient	5
Component(s), broken	5
No Known Device Problem	4
Absorption	2
Suture line separation	2
Implant, removal of	2
Deployment issue	1
No Information	1
Crack	1
Explanted	1
Premature explantation	1
Device Issue	1
Failure to deploy	1
Material disintegration	1
Tomographic pallet crack(s)	1
Total Device Problems	209

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

Recalls
Manufacturer		Recall Class	Date Posted
1	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Mar-06-2012
2	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Nov-30-2011