Atlas FDA

PHX

205 FDA 510(k) clearances · Product code

125 daysmedian time to decision
267 days90th percentile
205clearances measured

FDA profile

Official device name
Shoulder Prosthesis, Reverse Configuration
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Medical specialty
Orthopedic
Flags
Implant
FDA 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.
Adverse events (MAUDE)
2021: 1,404 · 2022: 1,342 · 2023: 1,402 · 2024: 2,142 · 2025: 2,889 · 2026: 1,758
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Veritas Shoulder System (K260556)Restor3D2026-07-01
Augment Off-Axis Instrument System (K261683)Zimmer, Inc.2026-06-16
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System (K260102)Stryker Corporation (Tornier, Inc.)2026-06-12
MSS - Humeral reverse liners extension (K261016)Medacta International, SA2026-06-10
Veritas Reverse Total Shoulder System (K253992)Restor3D2026-05-07
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (K252404)Biomet Orthopedics2026-04-15
Equinoxe® Shoulder System (K260583)Exactech, Inc.2026-04-14
InSet Reverse Total Shoulder System (K254128)Shoulder Innovations, Inc.2026-04-13
Blueprint Patient-Specific Instrumentation (K253674)Stryker Corporation (Tornier, S.A.S.)2026-04-03
INHANCE™ Reverse Shoulder System (K253624)Depuy Ireland UC2026-03-11
MSS - Monobloc stem (K250644)Medacta International S.A.2026-02-03
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (K252352)Lima Corporate S.P.A.2026-01-22
AltiVate Reverse® ADLC Glenosphere (K252567)Encore Medical L.P.2026-01-15
N22 EZ Glenosphere (K252516)Shoulder Innovations, Inc.2026-01-15
JARVIS Metaphyseal Stem (K254003)FH Industrie2026-01-09
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (K252788)Tornier, Inc.2026-01-08
MSS - Humeral reverse liners extension (K250338)Medacta International S.A.2025-10-31
JARVIS Diaphyseal Stem Standard (K253345)FH Industrie2025-10-29
Inset Reverse Total Shoulder System (K252221)Shoulder Innovations, Inc.2025-09-26
JARVIS Glenoid Reverse Shoulder Prosthesis (K252411)FH Industrie2025-08-28
AltiVate Reverse® Glenoid (K252141)Encore Medical L.P.2025-08-05
Equinoxe® Shoulder System (K243448)Exactech, Inc.2025-08-01
SMR Reverse HP Shoulder System (K243826)Lima Corporate S.P.A.2025-07-03
restor3d Reverse Total Shoulder Arthroplasty System (K243643)Restor3D2025-05-19
AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (K251184)Encore Medical L.P.2025-05-16
JARVIS Glenoid Reverse Shoulder Prosthesis (K242253)FH Industrie2024-11-25
Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (K241491)Stryker Corporation (Tornier, S.A.S.)2024-10-10
Equinoxe® Central Screw Baseplate System (K233482)Exactech, Inc.2024-07-18
AltiVate Reverse® Glenoid (K233481)Encore Medical L.P.2024-05-29
Augment Off-Axis Instrument System (K241043)Fix Surgical2024-05-15
Full Wedge Lateralized and Augmented Baseplates (K240278)Fx Shoulder USA, Inc.2024-05-15
Catalyst F1x Shoulder System (K234105)Catalyst Orthoscience, Inc.2024-04-05
Augment Off-Axis Instrument System (K233148)Fix Surgical2024-03-22
BLUEPRINT™ Patient Specific Instrumentation (K232265)Tornier S.A.S.2024-02-21
LINK Embrace Shoulder System - Reverse Configuration (K231445)Waldemar Link GmbH & Co. KG2023-11-16
Glenoid Reconstruction System – Full Wedge Baseplate (K231911)Medacta International S.A.2023-11-09
Catalyst R1 Reverse Shoulder System (K232583)Catalyst Orthoscience, Inc.2023-09-20
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (K223833)Exactech, Inc.2023-09-14
ARROW Off-Centred Humeral Insert (K232226)FH Industrie2023-08-29
FX V135(TM) Shoulder Prosthesis (K223801)Fx Shoulder USA, Inc.2023-06-05
Catalyst R1 Reverse Shoulder System (K223655)Catalyst Orthoscience, Inc.2023-05-09
Arthrex Univers Revers Monoblock Stem Size 4/33 (K230366)Arthrex, Inc.2023-04-10
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (K214001)Biomet Manufacturing Corp2023-03-15
INHANCETM Shoulder System – Humeral Stems and Stemless (K223211)Depuy Ireland UC2022-12-02
Glenoid Reconstruction System (K213459)Medacta International S.A.2022-11-23
Humeris® 135 Shoulder System (K222936)Fx Shoulder USA, Inc.2022-11-07
Tornier Perform Humeral System – Fracture (K220914)Tornier, Inc.2022-10-14
INHANCETM Reverse Glenoid Peripheral Posts (K221467)Depuy Ireland UC2022-08-31
Catalyst R1 Reverse Shoulder System (K213349)Catalyst Orthoscience, Inc.2022-06-23
FX V135 Shoulder Prosthesis (K213117)Fx Shoulder USA, Inc.2022-06-07
INHANCE™ Reverse Shoulder System (K212737)Depuy Ireland UC2022-04-21
PRIMA Humeral System and SMR Glenosphere Ø42 (K212800)Lima Corporate S.P.A.2022-02-25
ARROW Short Stem Humeral System (K202024)FH Industrie2021-11-30
LINK® Embrace Shoulder System - Reverse Configuration (K212992)Waldemar Link GmbH & Co. KG2021-11-18
Arthrex Modular Glenoid System-Titanium Glenosphere (K212415)Arthrex, Inc.2021-11-17
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation (K211359)Tornier, Inc.2021-11-12
Comprehensive® Convertible Glenoid - Vivacit-E Liner (K211729)Biomet Manufacturing Corp2021-11-04
Tomier Perform™ Reversed Glenoid Cannulated Glenospheres (K213124)Tornier, Inc.2021-10-26
GLOBAL UNITE™ Platform Shoulder System (K212710)Depuy Ireland UC2021-09-15
Univers Revers Modular Glenoid System, Standard Augment Baseplates (K211074)Arthrex, Inc.2021-09-02
Lateralized and Augmented Baseplates (K210790)Fx Shoulder USA, Inc.2021-08-25
Inset Reverse Total Shoulder System (K210533)Shoulder Innovations, Inc.2021-08-20
Tecomet Global Unite Short Stem Instrumentation (K211553)Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.2021-08-04
Catalyst R1 Reverse Shoulder System (K211991)Catalyst Orthoscience, Inc.2021-07-28
DELTA XTEND Reverse Shoulder System (K203694)Depuy Ireland UC2021-07-22
Bone Screws dia. 5,0 mm (K210717)Lima Corporate S.P.A.2021-07-12
OVOMotion Reverse Shoulder Arthroplasty System (K203375)Arthrosurface, Inc.2021-06-24
Humeral Eccentric Reverse Metaphysis (K210207)Medacta International S.A.2021-03-26
Shoulder System - TiNbN Coating (K203755)Medacta International S.A.2021-03-02
DELTA XTEND Reverse Shoulder System (K210167)DePuy Orthopaedics, Inc.2021-02-19
Comprehensive Vault Reconstruction System (K202232)Biomet Manufacturing Corp2021-02-19
Catalyst OrthoScience R1 Reverse Shoulder System (K202611)Catalyst Orthoscience, Inc.2021-02-12
LINK Embrace Shoulder System - Reverse Configuration (K200368)Waldemar Link GmbH & Co. KG2021-02-05
GLOBAL UNITE™ Platform Shoulder System (K202098)Depuy Ireland UC2020-11-25
SMR TT Augmented Glenoid System (K200171)Lima Corporate S.P.A.2020-11-19
Univers Revers Modular Glenoid System, Half Augment Baseplate (K200895)Arthrex, Inc.2020-08-13
Lateralized Glenosphere (K193175)Medacta Inernational SA2020-08-11
Humelock TiN Coated Glenosphere (K191146)Fx Shoulder USA, Inc.2020-07-15
Humeral Cup Stability & Humeral Cup 135/145o Stability (K193394)Fx Shoulder USA, Inc.2020-04-29
Comprehensive® Reverse Shoulder (K193373)Biomet, Inc.2020-04-15
Medacta Shoulder System (K192967)Medacta International S.A.2020-03-25
DELTA XTEND(TM) Reverse Shoulder System (K192855)Depuy(Ireland)2020-02-24
Glenoid Baseplate with Screw (K192799)Fx Shoulder USA, Inc.2020-02-21
Exactech® Equinoxe® Reverse Shoulder Glenospheres (K193098)Exactech, Inc.2020-02-20
Anatomical Shoulder System (K193099)Zimmer GmbH2020-01-29
Univers Revers Modular Glenoid System (Augemented baseplates) (K193372)Arthrex, Inc.2020-01-10
Arthrex Univers Revers Modular Glenoid System (K191960)Arthrex, Inc.2019-12-23
MyShoulder Placement Guides (K190738)Medacta International S.A.2019-12-13
Integra TITAN Reverse Shoulder System (K190588)Integra LifeSciences Corporation2019-12-02
SMR TT Augmented Glenoid System (K191746)Lima Corporate S.P.A.2019-11-22
32mm Glenosphere and Humeral Cup (K192206)Fx Shoulder USA, Inc.2019-10-08
Delta Xtend Revers Shoulder System (K192448)Depuy(Ireland)2019-10-04
Exactech Equinoxe Humeral Augmented Trays (K191561)Exactech, Inc.2019-08-20
Delta Xtend Reverse Shoulder System (K183077)Depuy(Ireland)2019-05-17
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid (K183696)Tornier, Inc.2019-01-30
Glenoid Polyaxial Non-locking Screws (K181826)Medacta International S.A.2018-12-10
Integra TITAN Reverse Shoulder System (K181999)Integra LifeSciences Corporation2018-10-12
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap (K182536)Exactech, Inc.2018-10-12
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay (K182039)Arthrex, Inc.2018-09-28
Comprehensive Reverse Shoulder System (K181611)Biomet Manufacturing Corp2018-09-24
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