TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
• Product Code: LZO
• Regulation Number: 888.3353
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANT SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	3
AESCULAP IMPLANTS SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
B-ONE ORTHO CORP.
	SUBSTANTIALLY EQUIVALENT	3
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
BIOMET UK LTD.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDO MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CORIN U.S.A.
	SUBSTANTIALLY EQUIVALENT	5
CORIN USA
	SUBSTANTIALLY EQUIVALENT	14
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	6
DEPUY (IRELAND)
	SUBSTANTIALLY EQUIVALENT	1
DEPUY FRANCE S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	5
DEPUY ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	9
GLOBAL MANUFACTURING TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
ICONACY ORTHOPEDIC IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	3
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	3
KYOCERA MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	8
MAXX ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	10
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	17
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	4
MERETE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
MERIL HEALTHCARE PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	8
MICROPORT ORTHOPEDICS INC. (MPO)
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
OMNI LIFE SCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNILIFE SCIENCE
	SUBSTANTIALLY EQUIVALENT	3
OMNILIFE SCIENCE INC.
	SUBSTANTIALLY EQUIVALENT	2
ORCHARD MEDICAL DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
OTIS BIOTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
RESPONSIVE ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERF
	SUBSTANTIALLY EQUIVALENT	4
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	5
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	14
TGM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOTAL JOINT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
TOTAL JOINT OTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
UNITED ORTHOPEDIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	8
WALDEMAR LINK GMBH & CO.KG
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	7
XERXES ARTHOPEDIX LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	10
ZIMMER, INC
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Inc	II	Aug-12-2011
2	Biomet, Inc.	II	Dec-18-2023
3	Biomet, Inc.	II	May-28-2020
4	Biomet, Inc.	II	Jan-13-2016
5	Biomet, Inc.	II	Apr-23-2012
6	Biomet, Inc.	II	Mar-02-2012
7	Biomet, Inc.	II	Jul-14-2009
8	Corin Ltd	II	Dec-19-2022
9	Corin USA Limited	II	Apr-22-2016
10	DePuy Orthopaedics, Inc.	II	Dec-17-2014
11	Encore Medical, LP	II	Sep-19-2023
12	Exactech, Inc.	II	Sep-09-2022
13	Exactech, Inc.	II	Aug-12-2021
14	Exactech, Inc.	II	Jul-22-2021
15	Exactech, Inc.	II	Jan-17-2017
16	Exactech, Inc.	II	Jul-05-2016
17	Exactech, Inc.	II	Jul-21-2014
18	Exactech, Inc.	II	Feb-05-2013
19	Howmedica Osteonics Corp.	II	Mar-31-2022
20	IMPLANTCAST GMBH	II	Jul-09-2021
21	IMPLANTCAST GMBH	II	Jul-20-2018
22	Medacta Usa Inc	II	Oct-19-2018
23	MicroPort Orthopedics Inc.	II	Jan-03-2017
24	MicroPort Orthopedics Inc.	III	Dec-01-2016
25	OMNIlife science Inc.	II	Jan-26-2021
26	OMNIlife science Inc.	II	Sep-05-2019
27	Omnilife Science Inc.	II	Jul-14-2015
28	Omnilife Science Inc.	II	Aug-15-2014
29	Ortho Development Corporation	II	Jan-13-2012
30	Ortho Development Corporation	II	Mar-16-2011
31	Orthopedic Alliance LLC	II	May-24-2013
32	Smith & Nephew Orthopaedics AG	II	Aug-19-2020
33	Smith & Nephew, Inc.	II	Aug-29-2017
34	Stryker Howmedica Osteonics Corp.	II	Sep-28-2012
35	Stryker Howmedica Osteonics Corp.	II	Nov-16-2011
36	Stryker Howmedica Osteonics Corp.	II	Mar-11-2010
37	Stryker Howmedica Osteonics Corp.	II	Jan-11-2010
38	Stryker Howmedica Osteonics Corp.	III	Sep-14-2009
39	Stryker Howmedica Osteonics Corp.	II	May-21-2009
40	Stryker Howmedica Osteonics Corp.	II	Jan-26-2009
41	Stryker Howmedica Osteonics Corp.	II	Jan-26-2009
42	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Feb-29-2024
43	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Aug-04-2023
44	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jan-14-2019
45	Zimmer Biomet, Inc.	II	Nov-07-2019
46	Zimmer Biomet, Inc.	II	Apr-16-2018
47	Zimmer Biomet, Inc.	II	Mar-14-2018
48	Zimmer Biomet, Inc.	II	Dec-29-2017
49	Zimmer Biomet, Inc.	II	Mar-20-2017
50	Zimmer GmbH	II	Dec-20-2018
51	Zimmer GmbH	II	Apr-26-2018
52	Zimmer Gmbh	II	Jul-26-2016
53	Zimmer Gmbh	II	Feb-20-2015
54	Zimmer Inc.	II	Jul-27-2009
55	Zimmer, Inc.	II	Feb-27-2015
56	Zimmer, Inc.	II	Nov-06-2012