|
Device |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer |
Product Code | HSX |
Regulation Number |
888.3520
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUE BELT TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BODYCAD LABORATORIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BODYCAD LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CONFORMIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CONSENSUS ORTHOPEDICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANTCAST GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYOCERA MEDICAL TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAKO SURGICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MATERIALISE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MATERIALISE NV |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OVERTURE RESURFACING INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
TORNIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Arthrex, Inc. |
II |
Nov-16-2017 |
2 |
Blue Belt Technologies MN |
II |
Jun-27-2014 |
3 |
Conformis Inc |
II |
Jul-15-2009 |
4 |
Encore Medical, LP |
II |
Nov-20-2020 |
5 |
Howmedica Osteonics Corp. |
II |
Apr-12-2023 |
6 |
Linkbio Corp. |
II |
May-04-2023 |
7 |
Smith & Nephew Inc |
II |
Mar-03-2010 |
8 |
Smith & Nephew, Inc. |
II |
May-31-2023 |
9 |
Smith & Nephew, Inc. |
II |
Apr-14-2023 |
10 |
Smith & Nephew, Inc. |
II |
May-27-2020 |
11 |
Stelkast Co |
II |
Nov-20-2009 |
12 |
Zimmer Biomet, Inc. |
II |
Mar-28-2018 |
13 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
14 |
Zimmer Biomet, Inc. |
II |
Jan-14-2018 |
15 |
Zimmer Biomet, Inc. |
II |
Feb-22-2016 |
16 |
Zimmer Inc. |
II |
Dec-22-2009 |
17 |
Zimmer, Inc. |
II |
Oct-25-2013 |
|
|
|
|