ClearanceBrief
Panels › Orthopedic › Product code KWS · Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Regulation 888.3660

3510(k)s in 12 months (191 all time)
4recalls in 12 months (153 all time)
131recalls that name a 510(k)
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Top companies in KWS

Company510(k)sRecalls
Encore Medical L.P.935
Exactech, Inc.823
Tornier246
Zimmer GmbH720
Biomet, Inc.421
DePuy Orthopaedics, Inc.911
Tournier, Inc.018
Smith & Nephew, Inc.116
Arthrex, Inc.150
Lima Corporate S.P.A.80
Decided510(k)Device and applicantCode
Jul 22, 2026K260721Tornier Perform Advanced Glenoid
Tornier, Inc.
KWS
Apr 6, 2026K254084AETOS Shoulder System - CONCELOC Glenoids
Smith & Nephew, Inc.
KWS
Nov 6, 2025K252418Catalyst F1x Shoulder System
Catalyst Orthoscience, Inc.
KWS
Oct 29, 2025K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0
Smith & Nephew, Inc.
KWS
Jan 30, 2025K241292MyShoulder Planner (5.3SSWPL)
Medacta International S.A., CH
KWS
Dec 6, 2024K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Stryker Corporation (Tornier, Inc.)
KWS
Sep 10, 2024K241609Tornier Humeral Reconstruction System (Tornier HRS)
Stryker Corporation (Tornier, Inc.)
KWS
Sep 26, 2023K230513Arthrex Univers Apex OptiFit Humeral Stem
Arthrex, Inc.
KWS
Jun 23, 2023K222592AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical L.P.
KWS
Jun 7, 2023K230572AETOS Shoulder System
Smith & Nephew, Inc.
KWS
Jan 3, 2023K220847AETOS Shoulder System
Smith & Nephew, Inc.
KWS
Nov 10, 2022K222317Catalyst EA Convertible Stemmed Shoulder
Catalyst Orthoscience, Inc.
KWS
Jul 7, 2022K213387AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical L.P.
KWS
May 13, 2022K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
Limacorporate, IT
KWS
Mar 11, 2022K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (H
Smith & Nephew, Inc.
KWS
Mar 4, 2022K212356Exactech® Equinoxe® Laser Cage Glenoid
Exactech, Inc.
KWS
Dec 10, 2021K212435Comprehensive Humeral Fracture Positioning Sleeves
Biomet, Inc.
KWS
Sep 3, 2021K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Art
Stryker GmbH
KWS
Jun 7, 2021K210050Augmented VaultLock Glenoid
Arthrex, Inc.
KWS
Apr 15, 2021K203315BLUEPRINT™ Patient Specific Instrumentation
Tornier S.A.S., FR
KWS
Apr 2, 2021K203230Global Shoulder and Delta CTA systems
Depuy Lnc.
KWS
Dec 23, 2020K203026AltiVate® Anatomic Pegged Glenoid with Markers
Encore Medical L.P.
KWS
Dec 16, 2020K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Art
Stryker GmbH
KWS
Feb 24, 2020K193180Alliance Augmented Glenoid
Zimmer, Inc.
KWS
Nov 15, 2019K191247SmartSPACE Shoulder System
Techmah Medical, LLC
KWS
Oct 23, 2019K191814Alliance Glenoid
Zimmer, Inc.
KWS
Jul 8, 2019K190286Materialise Glenoid Positioning System
Materialise NV, BE
KWS
Jun 14, 2019K191318AEQUALIS FLEX REVIVE Shoulder System
Tornier, Inc.
KWS
Jun 12, 2019K190521Aequalis Ascend Flex Shoulder System
Tornier S.A.S., FR
KWS
Apr 26, 2019K190290AltiVate Reverse Humeral Stem, 48mm
Encore Medical L.P.
KWS
Mar 8, 2019K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
Arthrex, Inc.
KWS
Feb 15, 2019K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Art
Stryker GmbH
KWS
Jan 25, 2019K183042SMR Lateralized Connectors with screws
Lima Corporate S.P.A., IT
KWS
Dec 21, 2018K181555Arthrex Fracture Adapter Hemi Shoulder Prosthesis
Arthrex, Inc.
KWS
Sep 27, 2018K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Art
Stryker GmbH
KWS
Sep 20, 2018K181420Aequalis Flex Revive Shoulder System
Tornier, Inc.
KWS
Mar 29, 2018K171841Arthrex Shoulder System
Arthrex, Inc.
KWS
Nov 3, 2017K172054Materialise Glenoid Positioning System
Materialise NV, BE
KWS
Oct 30, 2017K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Sm
Encore Medical L.P.
KWS
Oct 2, 2017K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Art
Stryker Trauma AG
KWS
Aug 16, 2017K170910Medacta Anatomic Shoulder Prosthesis
Medacta International S.A., CH
KWS
Jun 19, 2017K170893Materialise Glenoid Positioning System
Materialise NV, BE
KWS
Feb 22, 2017K162800BLUEPRINT Patient Specific Instrumentation
Tornier S.A.S., FR
KWS
Feb 10, 2017K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoi
Custom Orthopaedic Solutions, Inc.
KWS
Dec 27, 2016K161789BLUEPRINT Patient Specific Instrumentation
Tornier S.A.S., FR
KWS
Nov 23, 2016K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplas
Stryker GmbH, CH
KWS
Nov 21, 2016K162024AltiVate Anatomic Shoulder System
Encore Medical L.P.
KWS
Aug 29, 2016K161108Arthrex VaultLock Glenoid
Arthrex, Inc.
KWS
Jun 10, 2016K160975Aequalis PerFORM+ Shoulder System
Tornier, Inc.
KWS
Jun 10, 2016K160555BLUEPRINT Patient Specific Instrumentation
Tornier S.A.S., FR
KWS

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