|
Device |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented |
Product Code | LPH |
Regulation Number |
888.3358
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCORE9, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET MANUFACTURING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOMET MANUFACTUTING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
CARDO MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFORMIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CONSENSUS ORTHOPEDICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CONSENSUS ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
CORENTEC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORENTEC CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY INTERNATIONAL, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DEPUY ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY ORTHOPAEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ENCORE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
EXCERA ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOWMEDICA OSTEONICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ICONACY ORTHOPEDIC IMPLANTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
LIMACORPORATE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
MAKO SURGICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL S .A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC ADVANCED ENERGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROPORT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MICROPORT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVOSOURCE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNI LIFE SCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OMNILIFE SCIENCE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OMNLIFE SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ONKOS SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONKOS SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO DEVELOPMENT CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIPELINE BIOTECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIPELINE ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRECISION CASTING SOLUTION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS, PTY, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
17
|
STELKAST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TGM MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TGM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THECKEN COMPANIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN COMPANIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN COMPANIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TOTAL JOINT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TOTAL JOINT OTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNITED ORTHOPEDIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
WALDEMAR LINK GMBH & CO KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Mar-23-2023 |
2 |
Biomet, Inc. |
II |
Dec-17-2020 |
3 |
Biomet, Inc. |
II |
Aug-29-2015 |
4 |
Biomet, Inc. |
III |
Jun-11-2015 |
5 |
Biomet, Inc. |
II |
Feb-17-2015 |
6 |
Biomet, Inc. |
II |
Jun-05-2013 |
7 |
Biomet, Inc. |
II |
Jun-08-2011 |
8 |
Biomet, Inc. |
II |
May-26-2010 |
9 |
CORENTEC CO., LTD |
II |
Mar-13-2017 |
10 |
Conformis, Inc. |
II |
Nov-20-2020 |
11 |
Conformis, Inc. |
II |
Oct-08-2019 |
12 |
Conformis, Inc. |
II |
Jun-13-2019 |
13 |
Conformis, Inc. |
II |
Jan-12-2019 |
14 |
DePuy Orthopaedics, Inc. |
II |
May-22-2013 |
15 |
DePuy Orthopaedics, Inc. |
II |
Dec-20-2012 |
16 |
DePuy Orthopaedics, Inc. |
II |
Dec-19-2012 |
17 |
DePuy Orthopaedics, Inc. |
II |
Aug-17-2012 |
18 |
Djo Surgical |
II |
Mar-04-2014 |
19 |
Encore Medical, LP |
II |
Oct-12-2023 |
20 |
Encore Medical, LP |
II |
Oct-21-2022 |
21 |
Encore Medical, LP |
II |
Oct-20-2020 |
22 |
Encore Medical, LP |
II |
May-08-2020 |
23 |
Encore Medical, LP |
II |
Apr-10-2020 |
24 |
Encore Medical, Lp |
II |
Jul-19-2016 |
25 |
Exactech, Inc. |
II |
Jan-18-2024 |
26 |
Exactech, Inc. |
II |
Sep-09-2022 |
27 |
Exactech, Inc. |
II |
Jul-22-2021 |
28 |
Exactech, Inc. |
II |
Jan-17-2017 |
29 |
Exactech, Inc. |
II |
Feb-03-2014 |
30 |
Howmedica Osteonics Corp. |
II |
Apr-25-2024 |
31 |
Howmedica Osteonics Corp. |
II |
Feb-16-2022 |
32 |
Howmedica Osteonics Corp. |
II |
May-07-2020 |
33 |
Howmedica Osteonics Corp. |
II |
Nov-22-2019 |
34 |
Howmedica Osteonics Corp. |
II |
Mar-09-2018 |
35 |
Limacorporate S.p.A |
II |
Oct-21-2021 |
36 |
OMNIlife science Inc. |
II |
Oct-21-2019 |
37 |
OMNIlife science Inc. |
II |
Sep-05-2019 |
38 |
OMNIlife science Inc. |
II |
Jul-25-2018 |
39 |
OmniLife Science |
II |
Nov-16-2021 |
40 |
Omnilife Science Inc. |
II |
Aug-21-2015 |
41 |
Orthopedic Alliance LLC |
II |
May-24-2013 |
42 |
Signal Medical Corporation |
II |
Oct-22-2014 |
43 |
Smith & Nephew Inc |
II |
Dec-26-2013 |
44 |
Smith & Nephew Inc |
II |
Apr-21-2009 |
45 |
Smith & Nephew, Inc. |
II |
Mar-20-2019 |
46 |
Stryker Howmedica Osteonics Corp. |
II |
Jul-25-2016 |
47 |
Stryker Howmedica Osteonics Corp. |
II |
Nov-10-2015 |
48 |
Stryker Howmedica Osteonics Corp. |
II |
Sep-23-2015 |
49 |
Stryker Howmedica Osteonics Corp. |
II |
May-19-2015 |
50 |
Stryker Howmedica Osteonics Corp. |
II |
Mar-02-2010 |
51 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Sep-26-2023 |
52 |
Wright Medical Technology Inc |
II |
Oct-31-2012 |
53 |
Zimmer Biomet, Inc. |
II |
Oct-06-2020 |
54 |
Zimmer Biomet, Inc. |
II |
Nov-22-2019 |
55 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
56 |
Zimmer Biomet, Inc. |
II |
Jul-05-2018 |
57 |
Zimmer Biomet, Inc. |
II |
Apr-27-2018 |
58 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
59 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
60 |
Zimmer Biomet, Inc. |
II |
Mar-09-2018 |
61 |
Zimmer Biomet, Inc. |
II |
Feb-26-2018 |
62 |
Zimmer Biomet, Inc. |
II |
Jan-04-2018 |
63 |
Zimmer Biomet, Inc. |
II |
Mar-20-2017 |
64 |
Zimmer Biomet, Inc. |
II |
Jan-13-2017 |
65 |
Zimmer Biomet, Inc. |
II |
Mar-04-2016 |
66 |
Zimmer Biomet, Inc. |
II |
Feb-22-2016 |
67 |
Zimmer Gmbh |
II |
Feb-20-2015 |
68 |
Zimmer Inc. |
II |
Jun-26-2015 |
69 |
Zimmer Inc. |
II |
Dec-01-2011 |
70 |
Zimmer Inc. |
II |
Oct-14-2010 |
71 |
Zimmer Inc. |
II |
Aug-26-2010 |
72 |
Zimmer Inc. |
II |
Aug-12-2010 |
73 |
Zimmer Inc. |
II |
Nov-13-2009 |
74 |
Zimmer Inc. |
II |
Jul-27-2009 |
75 |
Zimmer Manufacturing B.V. |
II |
May-16-2016 |
76 |
Zimmer Manufacturing B.V. |
II |
Mar-12-2016 |
77 |
Zimmer Manufacturing B.V. |
II |
Dec-24-2014 |
78 |
Zimmer Manufacturing B.V. |
II |
Dec-17-2014 |
79 |
Zimmer Trabecular Metal Technology, Inc. |
II |
Jun-10-2016 |
80 |
Zimmer, Inc. |
II |
Mar-29-2023 |
81 |
Zimmer, Inc. |
II |
Jul-10-2014 |
82 |
Zimmer, Inc. |
II |
Jun-20-2014 |
83 |
Zimmer, Inc. |
II |
Apr-24-2014 |
84 |
Zimmer, Inc. |
II |
Feb-20-2014 |
85 |
Zimmer, Inc. |
II |
Oct-25-2013 |
86 |
Zimmer, Inc. |
II |
Feb-04-2013 |
87 |
Zimmer, Inc. |
II |
Nov-21-2012 |
|
|
|
|