TPLC - Total Product Life Cycle

Device	prosthesis, hip, cement restrictor
Regulation Description	Surgical mesh.
Product Code	JDK
Regulation Number	878.3300
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CENTERPULSE ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLEX
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
INTERPORE CROSS
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
KINETIKOS MEDICAL
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	7
NUVASIVE
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
OSTEOBIOLOGICS, INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
OSTEOIMPLANT TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
SPINAL CONCEPTS
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	2
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
SULZER
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	2

Device Problems
Device remains implanted	2
Unknown (for use when the device problem is not known)	2
No Information	1
Foreign material	1
Total Device Problems	6