|
Device |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
Regulation Description |
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
Product Code | JWH |
Regulation Number |
888.3560
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AMPLITUDE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B-ONE ORTHO, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIORAD MEDISYS PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFORMIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
CONFORMIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORENTEC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CPM MEDICAL CONSULTANTS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P DBA ENOVIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. (DBA ENOVIS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. DBA ENOVIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
IMPLANTCAST GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYOCERA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MATERIALISE NV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXX ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXX ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNILIFE SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOREMEDIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHALBY ADVANCED TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SMITH & NEPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SMITH&NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TJC LIFE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOTAL JOINT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TOTAL JOINT OTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNIK ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
MDR Year |
MDR Reports |
MDR Events |
2020 |
12591 |
12591 |
2021 |
9407 |
9407 |
2022 |
8361 |
8361 |
2023 |
8980 |
8986 |
2024 |
10861 |
11094 |
2025 |
976 |
989 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Aesculap Implant Systems LLC |
II |
Mar-13-2020 |
2 |
Biomet, Inc. |
II |
Jan-30-2023 |
3 |
Biomet, Inc. |
II |
Dec-23-2020 |
4 |
Biomet, Inc. |
II |
May-28-2020 |
5 |
Biomet, Inc. |
II |
Apr-03-2020 |
6 |
CORENTEC CO., LTD |
II |
May-31-2024 |
7 |
Conformis, Inc. |
II |
Apr-17-2024 |
8 |
Conformis, Inc. |
II |
Apr-08-2022 |
9 |
Conformis, Inc. |
II |
Aug-22-2020 |
10 |
Conformis, Inc. |
II |
Apr-01-2020 |
11 |
Corin Ltd |
II |
Nov-02-2023 |
12 |
Corin Ltd |
II |
Nov-21-2022 |
13 |
DePuy Orthopaedics, Inc. |
II |
Feb-09-2022 |
14 |
DePuy Orthopaedics, Inc. |
II |
Oct-07-2021 |
15 |
DePuy Orthopaedics, Inc. |
II |
Aug-25-2021 |
16 |
DePuy Orthopaedics, Inc. |
II |
Mar-29-2021 |
17 |
DePuy Orthopaedics, Inc. |
II |
Feb-09-2021 |
18 |
Encore Medical, LP |
II |
Dec-26-2024 |
19 |
Encore Medical, LP |
II |
Dec-23-2024 |
20 |
Encore Medical, LP |
II |
Oct-12-2023 |
21 |
Encore Medical, LP |
II |
Sep-19-2023 |
22 |
Encore Medical, LP |
II |
Feb-27-2023 |
23 |
Encore Medical, LP |
II |
Jun-09-2022 |
24 |
Encore Medical, LP |
II |
Jul-20-2021 |
25 |
Encore Medical, LP |
II |
Apr-30-2021 |
26 |
Exactech, Inc. |
II |
Jun-18-2024 |
27 |
Exactech, Inc. |
II |
Jan-18-2024 |
28 |
Exactech, Inc. |
II |
Oct-04-2021 |
29 |
Exactech, Inc. |
II |
Feb-26-2020 |
30 |
Howmedica Osteonics Corp. |
II |
Oct-07-2024 |
31 |
Howmedica Osteonics Corp. |
II |
Jan-31-2024 |
32 |
Howmedica Osteonics Corp. |
II |
Jun-03-2022 |
33 |
Howmedica Osteonics Corp. |
II |
Aug-19-2021 |
34 |
Howmedica Osteonics Corp. |
II |
Apr-09-2021 |
35 |
Limacorporate S.p.A |
II |
Dec-09-2023 |
36 |
Linkbio Corp. |
II |
Jun-01-2023 |
37 |
Materialise N.V. |
II |
Jul-20-2023 |
38 |
Ortho Development Corporation |
II |
May-06-2020 |
39 |
Smith & Nephew Inc |
II |
Oct-31-2024 |
40 |
Smith & Nephew Inc |
II |
Oct-30-2024 |
41 |
Smith & Nephew Inc |
II |
Sep-20-2023 |
42 |
Smith & Nephew Inc |
II |
May-16-2022 |
43 |
Smith & Nephew, Inc. |
II |
Oct-24-2023 |
44 |
Smith & Nephew, Inc. |
II |
Jul-20-2022 |
45 |
Smith & Nephew, Inc. |
II |
Jun-24-2021 |
46 |
Smith & Nephew, Inc. |
II |
Oct-16-2020 |
47 |
Smith & Nephew, Inc. |
II |
Aug-08-2020 |
48 |
Smith & Nephew, Inc. |
II |
Mar-17-2020 |
49 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Jul-18-2024 |
50 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Jul-03-2023 |
51 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Jul-12-2022 |
52 |
Zimmer, Inc. |
II |
Jan-28-2025 |
53 |
Zimmer, Inc. |
II |
Apr-22-2024 |
54 |
Zimmer, Inc. |
II |
Jul-05-2023 |
55 |
Zimmer, Inc. |
II |
Dec-09-2022 |
|
|
|
|