|
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
|
CONFORMIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORENTEC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORENTEC CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY INTERNATIONAL, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DEPUY ORTHOPAEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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
|
1
|
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K212187 Restoration® Modular Hip System
|
2. K220376 Acetabular Dome Hole Plug
|
LIMACORPORATE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL S .A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC ADVANCED ENERGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONKOS SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONKOS SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION CASTING SOLUTION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
STELKAST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THECKEN COMPANIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN COMPANIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN COMPANIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALDEMAR LINK GMBH & CO KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
MDR Year |
MDR Reports |
MDR Events |
2019 |
7125 |
7125 |
2020 |
5425 |
5425 |
2021 |
5981 |
5981 |
2022 |
5225 |
5225 |
2023 |
5375 |
5412 |
2024 |
5199 |
5199 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Mar-23-2023 |
2 |
Biomet, Inc. |
II |
Dec-17-2020 |
3 |
Conformis, Inc. |
II |
Nov-20-2020 |
4 |
Conformis, Inc. |
II |
Oct-08-2019 |
5 |
Conformis, Inc. |
II |
Jun-13-2019 |
6 |
Conformis, Inc. |
II |
Jan-12-2019 |
7 |
Encore Medical, LP |
II |
Oct-12-2023 |
8 |
Encore Medical, LP |
II |
Oct-21-2022 |
9 |
Encore Medical, LP |
II |
Oct-20-2020 |
10 |
Encore Medical, LP |
II |
May-08-2020 |
11 |
Encore Medical, LP |
II |
Apr-10-2020 |
12 |
Exactech, Inc. |
II |
Jan-18-2024 |
13 |
Exactech, Inc. |
II |
Sep-09-2022 |
14 |
Exactech, Inc. |
II |
Jul-22-2021 |
15 |
Howmedica Osteonics Corp. |
II |
Apr-25-2024 |
16 |
Howmedica Osteonics Corp. |
II |
Feb-16-2022 |
17 |
Howmedica Osteonics Corp. |
II |
May-07-2020 |
18 |
Howmedica Osteonics Corp. |
II |
Nov-22-2019 |
19 |
Limacorporate S.p.A |
II |
Oct-21-2021 |
20 |
Novosource, LLC |
II |
Nov-18-2024 |
21 |
OMNIlife science Inc. |
II |
Oct-21-2019 |
22 |
OMNIlife science Inc. |
II |
Sep-05-2019 |
23 |
OmniLife Science |
II |
Nov-16-2021 |
24 |
Smith & Nephew, Inc. |
II |
Mar-20-2019 |
25 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Sep-26-2023 |
26 |
Zimmer Biomet, Inc. |
II |
Oct-06-2020 |
27 |
Zimmer Biomet, Inc. |
II |
Nov-22-2019 |
28 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
29 |
Zimmer, Inc. |
II |
Mar-29-2023 |
|
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