Atlas FDA

KWS

191 FDA 510(k) clearances · Product code

98 daysmedian time to decision
214 days90th percentile
191clearances measured

FDA profile

Official device name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 1,358 · 2022: 1,269 · 2023: 1,750 · 2024: 2,121 · 2025: 2,315 · 2026: 1,574
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
Tornier Perform Advanced Glenoid (K260721)Tornier, Inc.2026-07-22
AETOS Shoulder System - CONCELOC Glenoids (K254084)Smith & Nephew, Inc.2026-04-06
Catalyst F1x Shoulder System (K252418)Catalyst Orthoscience, Inc.2025-11-06
AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416)Smith & Nephew, Inc.2025-10-29
MyShoulder Planner (5.3SSWPL) (K241292)Medacta International S.A.2025-01-30
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (K241878)Stryker Corporation (Tornier, Inc.)2024-12-06
Tornier Humeral Reconstruction System (Tornier HRS) (K241609)Stryker Corporation (Tornier, Inc.)2024-09-10
Arthrex Univers Apex OptiFit Humeral Stem (K230513)Arthrex, Inc.2023-09-26
AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592)Encore Medical L.P.2023-06-23
AETOS Shoulder System (K230572)Smith & Nephew, Inc.2023-06-07
AETOS Shoulder System (K220847)Smith & Nephew, Inc.2023-01-03
Catalyst EA Convertible Stemmed Shoulder (K222317)Catalyst Orthoscience, Inc.2022-11-10
AltiVate® Anatomic Shoulder AG e+™ with Markers (K213387)Encore Medical L.P.2022-07-07
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid (K213785)Limacorporate2022-05-13
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (K213827)Smith & Nephew, Inc.2022-03-11
Exactech® Equinoxe® Laser Cage Glenoid (K212356)Exactech, Inc.2022-03-04
Comprehensive Humeral Fracture Positioning Sleeves (K212435)Biomet, Inc.2021-12-10
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K210861)Stryker GmbH2021-09-03
Augmented VaultLock Glenoid (K210050)Arthrex, Inc.2021-06-07
BLUEPRINT™ Patient Specific Instrumentation (K203315)Tornier S.A.S.2021-04-15
Global Shoulder and Delta CTA systems (K203230)Depuy Lnc.2021-04-02
AltiVate® Anatomic Pegged Glenoid with Markers (K203026)Encore Medical L.P.2020-12-23
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K202289)Stryker GmbH2020-12-16
Alliance Augmented Glenoid (K193180)Zimmer, Inc.2020-02-24
SmartSPACE Shoulder System (K191247)Techmah Medical, LLC2019-11-15
Alliance Glenoid (K191814)Zimmer, Inc.2019-10-23
Materialise Glenoid Positioning System (K190286)Materialise NV2019-07-08
AEQUALIS FLEX REVIVE Shoulder System (K191318)Tornier, Inc.2019-06-14
Aequalis Ascend Flex Shoulder System (K190521)Tornier S.A.S.2019-06-12
AltiVate Reverse Humeral Stem, 48mm (K190290)Encore Medical L.P.2019-04-26
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads (K182799)Arthrex, Inc.2019-03-08
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K183039)Stryker GmbH2019-02-15
SMR Lateralized Connectors with screws (K183042)Lima Corporate S.P.A.2019-01-25
Arthrex Fracture Adapter Hemi Shoulder Prosthesis (K181555)Arthrex, Inc.2018-12-21
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K181742)Stryker GmbH2018-09-27
Aequalis Flex Revive Shoulder System (K181420)Tornier, Inc.2018-09-20
Arthrex Shoulder System (K171841)Arthrex, Inc.2018-03-29
Materialise Glenoid Positioning System (K172054)Materialise NV2017-11-03
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (K172351)Encore Medical L.P.2017-10-30
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K172210)Stryker Trauma AG2017-10-02
Medacta Anatomic Shoulder Prosthesis (K170910)Medacta International S.A.2017-08-16
Materialise Glenoid Positioning System (K170893)Materialise NV2017-06-19
BLUEPRINT Patient Specific Instrumentation (K162800)Tornier S.A.S.2017-02-22
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (K162697)Custom Orthopaedic Solutions, Inc.2017-02-10
BLUEPRINT Patient Specific Instrumentation (K161789)Tornier S.A.S.2016-12-27
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) (K161863)Stryker GmbH2016-11-23
AltiVate Anatomic Shoulder System (K162024)Encore Medical L.P.2016-11-21
Arthrex VaultLock Glenoid (K161108)Arthrex, Inc.2016-08-29
BLUEPRINT Patient Specific Instrumentation (K160555)Tornier S.A.S.2016-06-10
Aequalis PerFORM+ Shoulder System (K160975)Tornier, Inc.2016-06-10
Materialise Glenoid Positioning System (K153602)Materialise NV2016-04-26
SMR 3-Pegs Glenoids (K153722)Lima Corporate S.P.A.2016-04-06
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System (K160085)Zimmer GmbH2016-03-08
SmartBase for Arthrex Glenoid IRIS (K153215)Custom Orthopaedic Solutions, Inc.2016-02-19
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (K152047)Ascension Orthopedics2015-12-23
Remedy® Shoulder Spacer (K152267)Osteoremedies, LLC2015-12-15
Arthrex Univers Apex, Size 5 Stem (K153115)Arthrex, Inc.2015-11-23
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (K151500)Custom Orthopaedic Solutions2015-10-05
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (K151293)Tornier S.A.S.2015-09-24
SMR Modular Glenoid (K143256)Lima Corporate S.P.A.2015-05-28
Aequalis PerFORM+ Shoulder System (K150583)Tornier, Inc.2015-04-23
BLUEPRINT Patient Specific Instrumentation (K143374)Tornier S.A.S.2015-04-08
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System (K142403)Zimmer GmbH2014-11-24
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) (K142072)Custom Orthopaedic Solutions, Inc.2014-11-24
TITAN Modular Total Shoulder System (K142413)Ascension Orthopedics2014-11-14
SMR TT METAL BACK GLENOID (K133349)Lima Corporate S.P.A.2014-06-03
DEPUY GLOBAL UNITE SHOULDER SYSTEM (K133834)Depuy(Ireland)2014-04-03
EQUINOXE EXTRA SHORT HUMERAL HEAD (K140063)Exactech, Inc.2014-02-11
DUOCENTRIC REVERSED SHOULDER PROSTHESIS (K133462)Aston Medical2014-02-07
REVERSE SHOULDER PROSTHESIS MONOBLOCK (K130048)Encore Medical L.P.2013-10-29
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES (K131559)Materialise NV2013-09-27
ARTHREX UNIVERS APEX (K131633)Arthrex, Inc.2013-09-27
SEVIIN FRACTURE SHOULDER (K131277)Ingen Orthopedics, LLC2013-08-28
CAS PSI SHOULDER (K131129)Zimmer Cas2013-08-20
TITAN REVERSE SHOULDER SYSTEM (K130050)Ascension Orthopedic2013-06-18
SMR 3-PEGS GLENOIDS (K130642)Lima Corporate S.P.A.2013-06-12
LIMACORPORATE SMR CTA HUMERAL HEADS (K131112)Lima Corporate S.P.A.2013-06-07
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM (K130129)Arthrex, Inc.2013-05-31
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) (K123122)Cleveland Clinic2013-04-05
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ (K123982)Encore Medical L.P.2013-01-23
AEQUALIS ASCEND FLEX SHOULDER SYSTEM (K122698)Tornier S.A.S.2013-01-08
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT (K121220)Exactech, Inc.2012-11-20
ASCEND SHOULDER SYSTEM (K121493)Tornier, Inc.2012-06-20
ASCEND SHOULDER SYSTEM (K120794)Tornier, Inc.2012-04-13
TITAN MODULAR TOTAL SHOULDER SYSTEM (K112438)Ascension Orthopedic2012-04-11
ASCEND SHOULDER SYSTEM (K113413)Tornier, Inc.2012-03-09
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED (K120044)Arthrex, Inc.2012-03-08
PROMOS MODULAR SHOULDER SYSTEM (K113012)Smith & Nephew, Inc.2012-01-05
EXACTECH EQUINOXE CAGE GLENOIDS (K113309)Exactech, Inc.2011-12-08
AEQUALIS SHOULDER SYSTEM (K111902)Tornier2011-11-03
SMR SHOULDER SYSTEM- REVISION STEMS (K111212)Lima Corporate S.P.A.2011-07-28
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS (K110847)Lima Corporate S.P.A.2011-07-15
TOTAL SHOULDER SYSTEM (K111596)Shoulder Innovations, LLC2011-07-05
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT (K111379)Exactech, Inc.2011-06-08
TOTAL SHOULDER SYSTEM (K110905)Shoulder Innovations, LLC2011-05-24
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N (K103835)Howmedica Osteonics Corp.2011-05-05
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM (K110865)Tornier, Inc.2011-04-27
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM (K102924)Tornier, Inc.2011-01-31
TOTAL SHOULDER SYSTEM (K102670)Shoulder Innovations, LLC2011-01-24
ARTHREX UNIVERS II SHOULDER PROSTHESIS (K103466)Arthrex, Inc.2010-12-22
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