TPLC - Total Product Life Cycle

• Device: screw, fixation, bone
• Regulation Description: Smooth or threaded metallic bone fixation fastener.
• Product Code: HWC
• Regulation Number: 888.3040
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCUMED SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	6
ADVANCED ORTHOPAEDIC SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP
	SUBSTANTIALLY EQUIVALENT	2
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
ALPHATEC
	SUBSTANTIALLY EQUIVALENT	4
AMERICAN MEDICAL
	SUBSTANTIALLY EQUIVALENT	7
ARC SURGICAL LLC.
	SUBSTANTIALLY EQUIVALENT	3
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	27
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	4
ARTHROTEK, INC.
	SUBSTANTIALLY EQUIVALENT	4
ASCENSION ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPOSITES LTD.
	SUBSTANTIALLY EQUIVALENT	11
BIOMET
	SUBSTANTIALLY EQUIVALENT	28
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	4
BIONX
	SUBSTANTIALLY EQUIVALENT	10
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	3
CAYENNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
COAPT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	10
CONMED
	SUBSTANTIALLY EQUIVALENT	5
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	27
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	4
DJ ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	2
DOW
	SUBSTANTIALLY EQUIVALENT	2
EBI, L.P.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOURNITURES HOSPITALIERES INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	5
GLOBUS
	SUBSTANTIALLY EQUIVALENT	1
HAYES
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
IMPLEX
	SUBSTANTIALLY EQUIVALENT	1
INION
	SUBSTANTIALLY EQUIVALENT	11
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	4
KINETIKOS MEDICAL
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
LINVATEC
	SUBSTANTIALLY EQUIVALENT	18
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	3
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
MILLENNIUM
	SUBSTANTIALLY EQUIVALENT	2
MITEK
	SUBSTANTIALLY EQUIVALENT	9
MUSCULOSKELETAL TRANSPLANT FOUNDATION
	SUBSTANTIALLY EQUIVALENT	1
NEWDEAL
	SUBSTANTIALLY EQUIVALENT	9
NEXA ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	3
ONYX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	10
OPUSMED INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOHELIX SURGICAL DESIGN
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPAEDIC BIOSYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIC DESIGNS
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
ORTHOPEDIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	4
OSTEOMED
	SUBSTANTIALLY EQUIVALENT	10
OSTEOTECH, INC.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
PIONEER
	SUBSTANTIALLY EQUIVALENT	4
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
PLUS ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
REGENERATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
SCANDIUS BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SMALL BONE INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	27
SPINAL CONCEPTS
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	12
SULZER
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES
	SUBSTANTIALLY EQUIVALENT	26
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	5
T.A.G. MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE
	SUBSTANTIALLY EQUIVALENT	1
TORNIER
	SUBSTANTIALLY EQUIVALENT	1
TREU-INSTRUMENTE GMBH
	SUBSTANTIALLY EQUIVALENT	1
TRIAGE MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	5
U&I CORP.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	3
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	4
W.L. GORE & ASSOCIATES,INC
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	14
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	8

Device Problems
Unknown (for use when the device problem is not known)	433
Implant, removal of	234
Break	187
Fracture	129
No Information	104
No Known Device Problem	78
Device Issue	51
Electro-magnetic interference (EMI)	50
Device, or device fragments remain in patient	47
Migration of device or device component	43
Device remains implanted	43
Component(s), broken	38
Other (for use when an appropriate device code cannot be identified)	38
Loose	35
Loss of osseointegration	31
No code available	28
Malfunction	26
Material fragmentation	25
Difficult to insert	25
Explanted	21
Displacement	21
Implant breakage or physical damage	20
Detachment of device component	16
Disengaged	10
Loose or intermittent connection	9
Implant, repositioning of	9
Malposition of device	7
Tip breakage	6
Disassembly	6
Dislodged or dislocated	6
Slippage of device or device component	4
Suture line separation	4
Fitting problem	4
Failure to deploy	4
Material Protrusion	3
Device operates differently than expected	3
Foreign material	3
Tear, rip or hole in device packaging	3
Material disintegration	3
Loss of or failure to bond	3
Material frayed	3
Mislabeled	2
Metal shedding debris	2
Noise, Audible	2
Unsealed device packaging	2
Dislocated	2
Failure to disconnect	2
Tears, rips, holes in device, device material	1
Incomplete or missing packaging	1
Surgical graft, failure of	1
Material separation	1
Replace	1
Mechanical issue	1
Bent	1
Degraded	1
Failure to osseointegrate	1
Difficult to remove	1
Dislodged	1
Burrs, breakage of	1
Seal, defective	1
Protective measure issue	1
Incompatibility problem	1
Corrosion	1
Split	1
Contamination during use	1
Incorrect or inadequate result	1
Rejection	1
Positioning Issue	1
Unintended movement	1
Size incorrect for patient	1
Device, removal of (non-implant)	1
Failure to Adhere or Bond	1
Device expiration issue	1
Peeled	1
Device markings issue	1
Total Device Problems	1853

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	6	3	10	4	10	3
Class III	0	1	1	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumed LLC	II	May-14-2010
2	Acumed LLC	II	Oct-23-2009
3	Acumed LLC	II	Sep-20-2008
4	Acumed LLC	III	Sep-11-2008
5	Acumed LLC	II	Aug-28-2008
6	ArthroCare Corporation	II	Oct-14-2011
7	Biomet Microfixation, Inc.	II	Jul-22-2011
8	Biomet Microfixation, Inc.	II	Jan-04-2010
9	Biomet, Inc.	II	Jan-30-2013
10	Biomet, Inc.	II	Mar-21-2012
11	Biomet, Inc.	II	Mar-09-2011
12	Biomet, Inc.	II	Feb-02-2010
13	Biomet, Inc.	II	Jan-13-2010
14	Biomet, Inc.	II	Nov-12-2009
15	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Oct-25-2012
16	Encore Medical, Lp	II	Oct-25-2012
17	Encore Medical, Lp	II	Aug-06-2012
18	Extremity Medical LLC	II	Jan-30-2013
19	Extremity Medical LLC	II	Nov-18-2012
20	Innovatech Medical Resources L.P.	II	Jan-11-2012
21	Integra LifeSciences Corp.	II	Aug-15-2008
22	Integra LifeSciences Corporation	II	Apr-07-2010
23	Orthohelix Surgical Designs Inc	II	Oct-09-2012
24	Orthohelix Surgical Designs Inc	II	Jun-10-2010
25	Orthohelix Surgical Designs Inc	II	Apr-06-2010
26	Smith & Nephew, Inc. Endoscopy Division	II	Mar-19-2012
27	Smith & Nephew, Inc. Endoscopy Division	II	Mar-19-2008
28	Stryker Craniomaxillofacial Division	II	May-07-2010
29	Stryker Endoscopy	II	Dec-14-2010
30	Stryker Endoscopy	II	Aug-06-2008
31	Stryker Howmedica Osteonics Corp.	II	Nov-19-2012
32	Stryker Howmedica Osteonics Corp.	III	Sep-14-2009
33	Stryker Howmedica Osteonics Corp.	II	Sep-22-2008
34	Synthes USA HQ, Inc.	II	Mar-28-2013
35	Trilliant Surgical LTD	II	Apr-26-2010
36	Wright Medical Technology Inc	II	Jun-17-2011
37	Zimmer Inc.	II	Jan-26-2009
38	Zimmer, Inc.	II	Nov-06-2012