|
Device |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
Product Code | JWH |
Regulation Number |
888.3560
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
B-ONE ORTHO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
B-ONE ORTHO, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BEIJING AK MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIORAD MEDISYS PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFORMIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
CONFORMIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CORENTEC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CPM MEDICAL CONSULTANTS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENCORE MEDICAL, L.P DBA ENOVIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ENCORE MEDICAL, L.P. DBA ENOVIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANET, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L AND K BIOMED CORPORATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIMACORPORATE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MATERIALISE NV |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAXX ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRCOPORT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNI LIFE SCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNILIFE SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSTEOREMEDIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOREMEDIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION CASTING SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROOTLOC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SMITH & NEPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SMITH&NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STABIL ORTHOPAEDIC SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STELKAST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ORTHOPAEDICS (AKA HOWMEDICA OSTEONICS CORP.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECRES SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOTAL JOINT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TOTAL JOINT OTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
|
MDR Year |
MDR Reports |
MDR Events |
2018 |
14034 |
14034 |
2019 |
14986 |
14986 |
2020 |
12590 |
12590 |
2021 |
9406 |
9406 |
2022 |
8356 |
8356 |
2023 |
6024 |
6024 |
|
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 |
ConforMIS, Inc. |
II |
Oct-02-2018 |
7 |
ConforMIS, Inc. |
II |
Feb-13-2018 |
8 |
Conformis, Inc. |
II |
Apr-08-2022 |
9 |
Conformis, Inc. |
II |
Aug-22-2020 |
10 |
Conformis, Inc. |
II |
Apr-01-2020 |
11 |
Conformis, Inc. |
II |
Dec-12-2019 |
12 |
Conformis, Inc. |
II |
Apr-08-2019 |
13 |
Conformis, Inc. |
II |
Mar-30-2019 |
14 |
Corin Ltd |
II |
Nov-21-2022 |
15 |
DePuy Orthopaedics, Inc. |
II |
Feb-09-2022 |
16 |
DePuy Orthopaedics, Inc. |
II |
Oct-07-2021 |
17 |
DePuy Orthopaedics, Inc. |
II |
Aug-25-2021 |
18 |
DePuy Orthopaedics, Inc. |
II |
Mar-29-2021 |
19 |
DePuy Orthopaedics, Inc. |
II |
Feb-09-2021 |
20 |
DePuy Orthopaedics, Inc. |
II |
Aug-29-2018 |
21 |
DePuy Orthopaedics, Inc. |
II |
Apr-30-2018 |
22 |
Encore Medical, LP |
II |
Sep-19-2023 |
23 |
Encore Medical, LP |
II |
Feb-27-2023 |
24 |
Encore Medical, LP |
II |
Jun-09-2022 |
25 |
Encore Medical, LP |
II |
Jul-20-2021 |
26 |
Encore Medical, LP |
II |
Apr-30-2021 |
27 |
Encore Medical, Lp |
II |
Aug-31-2018 |
28 |
Encore Medical, Lp |
II |
Jan-10-2018 |
29 |
Exactech, Inc. |
II |
Oct-04-2021 |
30 |
Exactech, Inc. |
II |
Feb-26-2020 |
31 |
Exactech, Inc. |
II |
Apr-23-2019 |
32 |
Exactech, Inc. |
II |
Sep-20-2018 |
33 |
Howmedica Osteonics Corp. |
II |
Jun-03-2022 |
34 |
Howmedica Osteonics Corp. |
II |
Aug-19-2021 |
35 |
Howmedica Osteonics Corp. |
II |
Apr-09-2021 |
36 |
Linkbio Corp. |
II |
Jun-01-2023 |
37 |
Materialise N.V. |
II |
Jul-20-2023 |
38 |
OMNIlife science Inc. |
II |
Mar-19-2018 |
39 |
Ortho Development Corporation |
II |
May-06-2020 |
40 |
Signature Orthopedics Pty Limited |
II |
Feb-14-2019 |
41 |
Smith & Nephew Inc |
II |
Sep-20-2023 |
42 |
Smith & Nephew Inc |
II |
May-16-2022 |
43 |
Smith & Nephew, Inc. |
II |
Jul-20-2022 |
44 |
Smith & Nephew, Inc. |
II |
Jun-24-2021 |
45 |
Smith & Nephew, Inc. |
II |
Oct-16-2020 |
46 |
Smith & Nephew, Inc. |
II |
Aug-08-2020 |
47 |
Smith & Nephew, Inc. |
II |
Mar-17-2020 |
48 |
Smith & Nephew, Inc. |
II |
Sep-12-2019 |
49 |
Smith & Nephew, Inc. |
II |
Mar-22-2019 |
50 |
Smith & Nephew, Inc. |
II |
Oct-01-2018 |
51 |
Smith & Nephew, Inc. |
II |
Aug-22-2018 |
52 |
Smith & Nephew, Inc. |
II |
May-22-2018 |
53 |
United Orthopedic Corporation |
II |
Mar-19-2018 |
54 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Jul-03-2023 |
55 |
Waldemar Link GmbH & Co. KG (Mfg Site) |
II |
Jul-12-2022 |
56 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
57 |
Zimmer Biomet, Inc. |
II |
Sep-12-2019 |
58 |
Zimmer Biomet, Inc. |
II |
Apr-04-2019 |
59 |
Zimmer Biomet, Inc. |
II |
Feb-23-2019 |
60 |
Zimmer Biomet, Inc. |
II |
Dec-18-2018 |
61 |
Zimmer Biomet, Inc. |
II |
Nov-21-2018 |
62 |
Zimmer Biomet, Inc. |
II |
Sep-25-2018 |
63 |
Zimmer Biomet, Inc. |
II |
Jun-04-2018 |
64 |
Zimmer Biomet, Inc. |
II |
Jun-01-2018 |
65 |
Zimmer Biomet, Inc. |
II |
Jun-01-2018 |
66 |
Zimmer Biomet, Inc. |
II |
May-11-2018 |
67 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
68 |
Zimmer Biomet, Inc. |
II |
Feb-21-2018 |
69 |
Zimmer Biomet, Inc. |
II |
Feb-15-2018 |
70 |
Zimmer Trabecular Metal Technology, Inc. |
II |
Mar-11-2019 |
71 |
Zimmer, Inc. |
II |
Jul-05-2023 |
72 |
Zimmer, Inc. |
II |
Dec-09-2022 |
|
|
|
|