|
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
|
BIOMET |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFORMIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFORMIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
CONSENSUS ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY INTL., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY SYNTHES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENCORE MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAXX ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT ORTHOPEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROPORT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNI LIFE SCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNILIFE SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO DEVELOPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSTEOREMEDIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
STELKAST |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECRES SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOTAL JOINT ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
|
MDR Year |
MDR Reports |
MDR Events |
2016 |
7576 |
7576 |
2017 |
12256 |
12256 |
2018 |
14028 |
14028 |
2019 |
15001 |
15001 |
2020 |
12610 |
12610 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Aesculap Implant Systems LLC |
II |
Mar-13-2020 |
2 |
Aesculap, Inc. |
II |
Mar-03-2016 |
3 |
Arthrex, Inc. |
II |
Mar-19-2016 |
4 |
Biomet, Inc. |
II |
Dec-23-2020 |
5 |
Biomet, Inc. |
II |
May-28-2020 |
6 |
Biomet, Inc. |
II |
Apr-03-2020 |
7 |
ConforMIS, Inc. |
II |
Oct-02-2018 |
8 |
ConforMIS, Inc. |
II |
Feb-13-2018 |
9 |
ConforMIS, Inc. |
II |
Jan-10-2017 |
10 |
ConforMIS, Inc. |
II |
Nov-25-2016 |
11 |
Conformis, Inc. |
II |
Aug-22-2020 |
12 |
Conformis, Inc. |
II |
Apr-01-2020 |
13 |
Conformis, Inc. |
II |
Dec-12-2019 |
14 |
Conformis, Inc. |
II |
Apr-08-2019 |
15 |
Conformis, Inc. |
II |
Mar-30-2019 |
16 |
DePuy Orthopaedics, Inc. |
II |
Aug-29-2018 |
17 |
DePuy Orthopaedics, Inc. |
II |
Apr-30-2018 |
18 |
Encore Medical, Lp |
II |
Aug-31-2018 |
19 |
Encore Medical, Lp |
II |
Jan-10-2018 |
20 |
Encore Medical, Lp |
II |
Oct-20-2017 |
21 |
Encore Medical, Lp |
II |
Jun-30-2017 |
22 |
Encore Medical, Lp |
II |
Feb-03-2017 |
23 |
Encore Medical, Lp |
II |
Dec-14-2016 |
24 |
Encore Medical, Lp |
II |
Dec-06-2016 |
25 |
Encore Medical, Lp |
II |
Oct-28-2016 |
26 |
Exactech, Inc. |
II |
Feb-26-2020 |
27 |
Exactech, Inc. |
II |
Apr-23-2019 |
28 |
Exactech, Inc. |
II |
Sep-20-2018 |
29 |
Exactech, Inc. |
II |
Nov-20-2017 |
30 |
Exactech, Inc. |
II |
Jun-19-2017 |
31 |
Materialise USA LLC |
II |
Jun-09-2016 |
32 |
Medacta Usa Inc |
II |
Dec-20-2017 |
33 |
Medtronic Sofamor Danek USA Inc |
II |
Mar-21-2017 |
34 |
Medtronic Sofamor Danek USA Inc |
II |
Aug-23-2016 |
35 |
OMNIlife science Inc. |
II |
Mar-19-2018 |
36 |
Ortho Development Corporation |
II |
May-06-2020 |
37 |
Signature Orthopedics Pty Limited |
II |
Feb-14-2019 |
38 |
Smith & Nephew, Inc. |
II |
Oct-16-2020 |
39 |
Smith & Nephew, Inc. |
II |
Aug-08-2020 |
40 |
Smith & Nephew, Inc. |
II |
Mar-17-2020 |
41 |
Smith & Nephew, Inc. |
II |
Sep-12-2019 |
42 |
Smith & Nephew, Inc. |
II |
Mar-22-2019 |
43 |
Smith & Nephew, Inc. |
II |
Oct-01-2018 |
44 |
Smith & Nephew, Inc. |
II |
Aug-22-2018 |
45 |
Smith & Nephew, Inc. |
II |
May-22-2018 |
46 |
Smith & Nephew, Inc. |
II |
Nov-16-2017 |
47 |
Smith & Nephew, Inc. |
II |
Jun-12-2017 |
48 |
Smith & Nephew, Inc. |
II |
Apr-21-2016 |
49 |
Smith & Nephew, Inc. |
II |
Feb-17-2016 |
50 |
Smith & Nephew, Inc. |
II |
Jan-04-2016 |
51 |
Stanmore Implants Worldwide Ltd. |
II |
May-09-2016 |
52 |
Stryker Howmedica Osteonics Corp. |
II |
Aug-09-2016 |
53 |
United Orthopedic Corporation |
II |
Mar-19-2018 |
54 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
55 |
Zimmer Biomet, Inc. |
II |
Sep-12-2019 |
56 |
Zimmer Biomet, Inc. |
II |
Apr-04-2019 |
57 |
Zimmer Biomet, Inc. |
II |
Feb-23-2019 |
58 |
Zimmer Biomet, Inc. |
II |
Dec-18-2018 |
59 |
Zimmer Biomet, Inc. |
II |
Nov-21-2018 |
60 |
Zimmer Biomet, Inc. |
II |
Sep-25-2018 |
61 |
Zimmer Biomet, Inc. |
II |
Jun-04-2018 |
62 |
Zimmer Biomet, Inc. |
II |
Jun-01-2018 |
63 |
Zimmer Biomet, Inc. |
II |
Jun-01-2018 |
64 |
Zimmer Biomet, Inc. |
II |
May-11-2018 |
65 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
66 |
Zimmer Biomet, Inc. |
II |
Feb-21-2018 |
67 |
Zimmer Biomet, Inc. |
II |
Feb-15-2018 |
68 |
Zimmer Biomet, Inc. |
II |
May-18-2017 |
69 |
Zimmer Biomet, Inc. |
II |
Mar-27-2017 |
70 |
Zimmer Biomet, Inc. |
II |
Feb-16-2017 |
71 |
Zimmer Biomet, Inc. |
II |
Jan-28-2017 |
72 |
Zimmer Biomet, Inc. |
II |
Oct-18-2016 |
73 |
Zimmer Biomet, Inc. |
II |
Oct-03-2016 |
74 |
Zimmer Biomet, Inc. |
II |
Feb-22-2016 |
75 |
Zimmer Manufacturing B.V. |
II |
Apr-06-2016 |
76 |
Zimmer Manufacturing B.V. |
II |
Mar-12-2016 |
77 |
Zimmer Manufacturing B.V. |
II |
Jan-05-2016 |
78 |
Zimmer Trabecular Metal Technology, Inc. |
II |
Mar-11-2019 |
|
|
|
|