TPLC - Total Product Life Cycle

Device	prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product Code	HSX
Regulation Number	888.3520
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
CONFORMIS, INC.
	SUBSTANTIALLY EQUIVALENT	7
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
DOW
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
JOINT MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	5
MATERIALISE N.V.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	7
STELKAST
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	2
SULZER
	SUBSTANTIALLY EQUIVALENT	1
TORNIER
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	7
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1

Device Problems
Unknown (for use when the device problem is not known)	8
Fitting problem	5
No Information	5
No code available	5
Loose or intermittent connection	4
Explanted	4
Loose	3
Difficult to insert	3
Device remains implanted	3
Fracture	2
Device expiration issue	2
Break	2
Detachment of device component	2
Implant, removal of	2
Foreign material present in device	2
Naturally worn	2
Loss of osseointegration	1
Component(s), worn	1
Component(s), broken	1
Loss of or failure to bond	1
Migration of device or device component	1
Other (for use when an appropriate device code cannot be identified)	1
Device damaged prior to use	1
Incomplete or missing packaging	1
Total Device Problems	62