|
Device |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer |
Product Code | MBH |
Regulation Number |
888.3565
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOMET MANUFACTURING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CONFORMIS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFORMIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONSENSUS ORTHOPEDICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONSENSUS ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY (IRELAND) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENCORE MEDICAL, L.P. DBA DJO SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MATERIALISE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAXX ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MICROPORT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OPTIMOTION IMPLANTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIGNAL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TOTAL JOINT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIK ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER TRABECULAR METAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Apr-22-2024 |
2 |
Biomet, Inc. |
II |
Oct-08-2020 |
3 |
Biomet, Inc. |
II |
May-28-2020 |
4 |
Biomet, Inc. |
II |
Mar-25-2016 |
5 |
DePuy Orthopaedics, Inc. |
II |
Mar-29-2024 |
6 |
DePuy Orthopaedics, Inc. |
II |
Jul-20-2015 |
7 |
DePuy Orthopaedics, Inc. |
I |
Feb-15-2013 |
8 |
Encore Medical, LP |
II |
Dec-07-2023 |
9 |
Encore Medical, LP |
II |
Nov-07-2023 |
10 |
Encore Medical, LP |
II |
Apr-12-2023 |
11 |
Encore Medical, LP |
II |
Oct-07-2020 |
12 |
Howmedica Osteonics Corp. |
II |
Mar-06-2024 |
13 |
Howmedica Osteonics Corp. |
II |
May-30-2023 |
14 |
Howmedica Osteonics Corp. |
II |
Mar-08-2021 |
15 |
Howmedica Osteonics Corp. |
II |
Sep-27-2019 |
16 |
Howmedica Osteonics Corp. |
II |
Apr-24-2018 |
17 |
Howmedica Osteonics Corp. |
II |
Apr-20-2018 |
18 |
MicroPort Orthopedics Inc. |
I |
Sep-08-2016 |
19 |
Smith & Nephew, Inc. |
II |
Jan-28-2020 |
20 |
Smith & Nephew, Inc. |
II |
Oct-22-2018 |
21 |
Smith & Nephew, Inc. |
II |
Jun-11-2018 |
22 |
Smith & Nephew, Inc. |
II |
May-21-2018 |
23 |
Stryker Howmedica Osteonics Corp. |
II |
Sep-13-2016 |
24 |
Stryker Howmedica Osteonics Corp. |
II |
Aug-11-2016 |
25 |
Stryker Howmedica Osteonics Corp. |
II |
Aug-14-2015 |
26 |
Stryker Howmedica Osteonics Corp. |
II |
Mar-16-2015 |
27 |
Stryker Howmedica Osteonics Corp. |
I |
Apr-12-2013 |
28 |
Stryker Howmedica Osteonics Corp. |
II |
Jan-08-2009 |
29 |
Wright Medical Technology Inc |
III |
Dec-08-2009 |
30 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
31 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
32 |
Zimmer Biomet, Inc. |
II |
Apr-25-2017 |
33 |
Zimmer Biomet, Inc. |
II |
Jun-07-2016 |
34 |
Zimmer Biomet, Inc. |
II |
Feb-22-2016 |
35 |
Zimmer Inc. |
II |
Jul-27-2012 |
36 |
Zimmer Inc. |
II |
May-10-2011 |
37 |
Zimmer Inc. |
II |
Apr-14-2011 |
38 |
Zimmer Trabecular Metal Technology, Inc. |
II |
Jun-10-2016 |
39 |
Zimmer Trabecular Metal Technology, Inc. |
II |
Mar-26-2015 |
40 |
Zimmer, Inc. |
II |
Mar-12-2015 |
|
|
|
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