ClearanceBrief
Panels › Orthopedic › Product code PHX · Class 2

Shoulder Prosthesis, Reverse Configuration

Regulation 888.3660

18510(k)s in 12 months (207 all time)
11recalls in 12 months (68 all time)
68recalls that name a 510(k)
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Top companies in PHX

Company510(k)sRecalls
Exactech, Inc.2123
Encore Medical L.P.1816
Tornier183
Biomet Manufacturing Corp150
Zimmer GmbH105
DePuy Orthopaedics, Inc.68
Medacta International S.A.130
Arthrex, Inc.110
Lima Corporate S.P.A.110
Biomet Corporation46
Decided510(k)Device and applicantCode
Jun 23, 2022K213349Catalyst R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
PHX
Jun 7, 2022K213117FX V135 Shoulder Prosthesis
Fx Shoulder USA, Inc.
PHX
Apr 21, 2022K212737INHANCE™ Reverse Shoulder System
Depuy Ireland UC, IE
PHX
Feb 25, 2022K212800PRIMA Humeral System and SMR Glenosphere Ø42
Lima Corporate S.P.A., IT
PHX
Nov 30, 2021K202024ARROW Short Stem Humeral System
FH Industrie, FR
PHX
Nov 18, 2021K212992LINK® Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG, DE
PHX
Nov 17, 2021K212415Arthrex Modular Glenoid System-Titanium Glenosphere
Arthrex, Inc.
PHX
Nov 12, 2021K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
Tornier, Inc.
PHX
Nov 4, 2021K211729Comprehensive® Convertible Glenoid - Vivacit-E Liner
Biomet Manufacturing Corp
PHX
Oct 26, 2021K213124Tomier Perform™ Reversed Glenoid Cannulated Glenospheres
Tornier, Inc.
PHX
Sep 15, 2021K212710GLOBAL UNITE™ Platform Shoulder System
Depuy Ireland UC, IE
PHX
Sep 2, 2021K211074Univers Revers Modular Glenoid System, Standard Augment Baseplates
Arthrex, Inc.
PHX
Aug 25, 2021K210790Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
PHX
Aug 20, 2021K210533Inset Reverse Total Shoulder System
Shoulder Innovations, Inc.
PHX
Aug 4, 2021K211553Tecomet Global Unite Short Stem Instrumentation
Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
PHX
Jul 28, 2021K211991Catalyst R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
PHX
Jul 22, 2021K203694DELTA XTEND Reverse Shoulder System
Depuy Ireland UC, IE
PHX
Jul 12, 2021K210717Bone Screws dia. 5,0 mm
Lima Corporate S.P.A., IT
PHX
Jun 24, 2021K203375OVOMotion Reverse Shoulder Arthroplasty System
Arthrosurface, Inc.
PHX
Mar 26, 2021K210207Humeral Eccentric Reverse Metaphysis
Medacta International S.A., CH
PHX
Mar 2, 2021K203755Shoulder System - TiNbN Coating
Medacta International S.A., CH
PHX
Feb 19, 2021K210167DELTA XTEND Reverse Shoulder System
DePuy Orthopaedics, Inc.
PHX
Feb 19, 2021K202232Comprehensive Vault Reconstruction System
Biomet Manufacturing Corp
PHX
Feb 12, 2021K202611Catalyst OrthoScience R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
PHX
Feb 5, 2021K200368LINK Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG, DE
PHX
Nov 25, 2020K202098GLOBAL UNITE™ Platform Shoulder System
Depuy Ireland UC, IE
PHX
Nov 19, 2020K200171SMR TT Augmented Glenoid System
Lima Corporate S.P.A., IT
PHX
Aug 13, 2020K200895Univers Revers Modular Glenoid System, Half Augment Baseplate
Arthrex, Inc.
PHX
Aug 11, 2020K193175Lateralized Glenosphere
Medacta Inernational SA, CH
PHX
Jul 15, 2020K191146Humelock TiN Coated Glenosphere
Fx Shoulder USA, Inc.
PHX
Apr 29, 2020K193394Humeral Cup Stability & Humeral Cup 135/145o Stability
Fx Shoulder USA, Inc.
PHX
Apr 15, 2020K193373Comprehensive® Reverse Shoulder
Biomet, Inc.
PHX
Mar 25, 2020K192967Medacta Shoulder System
Medacta International S.A., CH
PHX
Feb 24, 2020K192855DELTA XTEND(TM) Reverse Shoulder System
Depuy(Ireland), IE
PHX
Feb 21, 2020K192799Glenoid Baseplate with Screw
Fx Shoulder USA, Inc.
PHX
Feb 20, 2020K193098Exactech® Equinoxe® Reverse Shoulder Glenospheres
Exactech, Inc.
PHX
Jan 29, 2020K193099Anatomical Shoulder System
Zimmer GmbH, CH
PHX
Jan 10, 2020K193372Univers Revers Modular Glenoid System (Augemented baseplates)
Arthrex, Inc.
PHX
Dec 23, 2019K191960Arthrex Univers Revers Modular Glenoid System
Arthrex, Inc.
PHX
Dec 13, 2019K190738MyShoulder Placement Guides
Medacta International S.A., CH
PHX
Dec 2, 2019K190588Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation
PHX
Nov 22, 2019K191746SMR TT Augmented Glenoid System
Lima Corporate S.P.A., IT
PHX
Oct 8, 2019K19220632mm Glenosphere and Humeral Cup
Fx Shoulder USA, Inc.
PHX
Oct 4, 2019K192448Delta Xtend Revers Shoulder System
Depuy(Ireland), IE
PHX
Aug 20, 2019K191561Exactech Equinoxe Humeral Augmented Trays
Exactech, Inc.
PHX
May 17, 2019K183077Delta Xtend Reverse Shoulder System
Depuy(Ireland), IE
PHX
Jan 30, 2019K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
Tornier, Inc.
PHX
Dec 10, 2018K181826Glenoid Polyaxial Non-locking Screws
Medacta International S.A., CH
PHX
Oct 12, 2018K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equ
Exactech, Inc.
PHX
Oct 12, 2018K181999Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation
PHX

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