|
Device |
shoulder prosthesis, reverse configuration |
Definition |
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint. |
Product Code | PHX |
Regulation Number |
888.3660
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHROSURFACE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTON MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET MANUFACTURING CORP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET MANUFACTURING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
BIOMET MANUFACTURING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CATALYST ORTHOSCIENCE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CATALYST ORTHOSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DEPUY (IRELAND) |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY FRANCE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
DEPUY ORTHOPAEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY(IRELAND) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DJO GLOBAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DJO SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENCORE MEDICAL, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
EXACTECH INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EXACTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
FH INDUSTRIE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FIX SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOURNITURES HOSPITALIERES INDUSTRIE |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FX SHOULDER USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FX SHOULDER USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
FX SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOWMEDICA OSTEONICS CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INGEN ORTHOPEDICS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRA LIFESCIENCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
LIMACORPORATE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIMACORPORATE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
MEDACTA INERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
MEDACTA INTERNATIONAL, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHOULDER INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYMMETRY MEDICAL MANUFACTURING INC. DBA TECOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TORNIER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K131231 AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERS ...
|
2. K140082 AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
|
3. K140478 AEQUALIS REVERSED SHOULDER PROSTHESIS
|
4. K141345 AEQUALIS FX2
|
5. K152966 Aequalis Fx2
|
6. K232265 BLUEPRINT™ Patient Specific Instrumentation
|
TORNIER SAS |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
1. K131231 AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERS ...
|
2. K140082 AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
|
3. K140478 AEQUALIS REVERSED SHOULDER PROSTHESIS
|
4. K141345 AEQUALIS FX2
|
5. K152966 Aequalis Fx2
|
6. K232265 BLUEPRINT™ Patient Specific Instrumentation
|
TORNIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
TORNIER, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Feb-17-2021 |
2 |
Biomet, Inc. |
II |
Oct-09-2020 |
3 |
Biomet, Inc. |
II |
Jun-09-2020 |
4 |
Biomet, Inc. |
II |
May-28-2020 |
5 |
Biomet, Inc. |
II |
Apr-20-2020 |
6 |
Biomet, Inc. |
II |
Mar-31-2020 |
7 |
DePuy Orthopaedics, Inc. |
II |
Jan-11-2022 |
8 |
Encore Medical, LP |
II |
Jan-02-2024 |
9 |
Encore Medical, LP |
II |
Dec-12-2023 |
10 |
Encore Medical, LP |
II |
Nov-08-2023 |
11 |
Encore Medical, LP |
II |
Oct-12-2023 |
12 |
Encore Medical, LP |
II |
Sep-19-2023 |
13 |
Encore Medical, LP |
II |
Sep-25-2020 |
14 |
Encore Medical, Lp |
II |
Mar-05-2018 |
15 |
Encore Medical, Lp |
II |
Jan-09-2016 |
16 |
Encore Medical, Lp |
II |
Oct-16-2015 |
17 |
Exactech, Inc. |
II |
Mar-29-2024 |
18 |
Exactech, Inc. |
II |
Jun-29-2021 |
19 |
Exactech, Inc. |
II |
Oct-29-2020 |
20 |
Exactech, Inc. |
II |
Sep-25-2020 |
21 |
Exactech, Inc. |
II |
Jan-28-2020 |
22 |
Exactech, Inc. |
II |
Feb-26-2019 |
23 |
FX SHOULDER |
II |
Jan-29-2024 |
24 |
Tornier, Inc |
II |
Jan-19-2024 |
25 |
Tornier, Inc |
II |
Oct-13-2023 |
26 |
Tornier, Inc |
II |
Nov-14-2019 |
|
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