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

FDA product code KWT · 69 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3650
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-06-22 – 2026-09-08

KWT 2026-09-08

N22 Offset Humeral Head

Applicant Shoulder Innovations, Inc.

K number K262173

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KWT 2025-12-01

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

Applicant Exactech, Inc.

K number K250713

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KWT 2025-10-30

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Applicant Tornier, Inc.

K number K251686

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KWT 2025-03-10

AGILON® XO Shoulder Replacement System

Applicant Implantcast GmbH

K number K241944

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KWT 2025-02-11

InSet Total Shoulder System

Applicant Shoulder Innovations, Inc.

K number K241817

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KWT 2024-02-16

AGILON® XO Shoulder Replacement System

Applicant Implantcast GmbH

K number K231657

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KWT 2023-07-12

Comprehensive Segmental Revision System(SRS)

Applicant Biomet Orthopedics

K number K223631

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KWT 2022-09-28

AGILON XO Shoulder System

Applicant Implantcast GmbH

K number K222482

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KWT 2021-06-21

LINK Embrace Shoulder System- Anatomical Configuration

Applicant Waldemar Link GmbH & Co. KG

K number K210899

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KWT 2020-07-16

TiN Coated Humeral Head

Applicant Fx Shoulder USA, Inc.

K number K191698

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KWT 2019-11-29

Shoulder Innovations Total Shoulder System

Applicant Shoulder Innovations, Inc.

K number K192365

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KWT 2019-09-11

Catalyst OrthoScience CSR Shoulder System

Applicant Catalyst Orthoscience, Inc.

K number K191811

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KWT 2019-06-05

Signature ONE System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K number K190595

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KWT 2019-01-11

Catalyst CSR Press-Fit Humeral Components

Applicant Catalyst Orthoscience, Inc.

K number K182500

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KWT 2018-07-12

Catalyst CSR Shoulder System

Applicant Catalyst Orthoscience, Inc.

K number K181287

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KWT 2018-03-09

Catalyst CSR 3 Peg Glenoids

Applicant Catalyst Orthoscience, Inc.

K number K173812

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KWT 2017-02-27

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

Applicant Exactech, Inc.

K number K162903

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KWT 2016-06-24

SMR Shoulder System

Applicant Lima Corporate S.P.A.

K number K161476

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KWT 2016-05-11

Catalyst CSR Shoulder System

Applicant Catalyst Orthoscience, LLC

K number K152825

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KWT 2013-08-13

HUMELOCK II CEMENTED SHOULDER SYSTEM

Applicant Fx Solutions

K number K123814

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KWT 2012-10-11

ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS

Applicant Zimmer, Inc.

K number K121543

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KWT 2011-12-15

COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)

Applicant Biomet, Inc.

K number K111746

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KWT 2011-09-02

BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION

Applicant Zimmer, Inc.

K number K110791

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KWT 2011-05-17

EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD

Applicant Exactech, Inc.

K number K110706

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KWT 2011-03-15

ANA0TOMICAL SHOULDER TM COMBINED SYSTEM

Applicant Zimmer GmbH

K number K103404

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KWT 2011-01-28

LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,

Applicant Lima-Lto S.P.A.

K number K101263

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KWT 2010-12-10

LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,

Applicant Lima-Lto S.P.A.

K number K100858

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KWT 2007-07-20

NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM

Applicant Nexa Orthopedics, Inc.

K number K071147

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KWT 2005-04-11

ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM

Applicant Zimmer, Inc.

K number K050761

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KWT 2005-02-09

DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM

Applicant Biomet, Inc.

K number K043505

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KWT 2005-01-28

MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD

Applicant Biomet Manufacturing Corp

K number K042321

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KWT 2004-09-01

ZIMMER TRABECULAR METAL HUMERAL STEM

Applicant Zimmer, Inc.

K number K041549

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KWT 2003-09-05

INTERLOK BIO-MODULAR HUMERAL STEMS

Applicant Biomet, Inc.

K number K032507

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KWT 2003-06-04

BIO-MODULAR SHOULDER SYSTEM

Applicant Biomet, Inc.

K number K030710

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KWT 2002-12-13

COMPREHENSIVE HUMERAL FRACTURE SYSTEM

Applicant Biomet Orthopedics, Inc.

K number K023063

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KWT 2002-12-10

THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306

Applicant Implex Corp.

K number K022377

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KWT 2002-09-24

SHORT AND LONG SOFT TISSUE ATTACHMENT

Applicant Biomet, Inc.

K number K022079

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KWT 2002-01-30

3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM

Applicant Biomet Orthopedics, Inc.

K number K020045

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KWT 2002-01-09

EPOCA CODR STEM AND HEAD

Applicant Stelkast Company

K number K014049

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KWT 2001-10-11

EPOCA CUSTOM OFFSET SHOULDER SYSTEM

Applicant Argomedical AG

K number K010869

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KWT 2000-10-06

BIOMET BI-POLAR SHOULDER SYSTEM

Applicant Biomet, Inc.

K number K002998

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KWT 1999-08-18

BIPOLAR SHOULDER PROSTHESIS

Applicant Biomet, Inc.

K number K991585

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KWT 1999-06-29

GRIT BLASTED HUMERAL STEM

Applicant Encore Orthopedics, Inc.

K number K991603

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KWT 1999-01-14

GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD

Applicant DePuy Orthopaedics, Inc.

K number K984541

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KWT 1998-12-17

NEW ZIMMER SHOULDER SYSTEM

Applicant Zimmer, Inc.

K number K982981

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KWT 1997-02-27

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS

Applicant Intermedics Orthopedics

K number K970567

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KWT 1996-09-03

SELECT SHOULDER COCR HUMERAL STEM COMPONENT

Applicant Intermedics Orthopedics

K number K962315

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KWT 1996-08-26

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD

Applicant Endotec, Inc.

K number K960424

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KWT 1996-08-09

SELECT SHOULDER PEGGED ALL-POLY GLENOID

Applicant Intermedics Orthopedics

K number K962244

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KWT 1996-08-09

SELECT SHOULDER KEELED ALL-POLY GLENOIDS

Applicant Intermedics Orthopedics

K number K962238

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KWT 1996-08-05

COCR BI-ANGULAR HUMERAL COMPONENT

Applicant Biomet, Inc.

K number K961571

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KWT 1995-08-29

KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM

Applicant Kirschner Medical Corp.

K number K940537

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KWT 1994-10-14

PROXIMAL HUMERAL REPLACEMENT SYSTEM

Applicant Biomet, Inc.

K number K925613

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KWT 1994-05-09

SELECT(R) SHOULDER ALL-POLY GLENOID

Applicant Intermedics Orthopedics

K number K931114

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KWT 1992-12-10

NEER TYPE SHOULDER PROSTHESIS SYSTEM

Applicant Osteo Technology, Inc.

K number K922865

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KWT 1992-03-11

BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD

Applicant Biomet, Inc.

K number K915596

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KWT 1992-01-16

GLOBAL TOTAL SHOULDER

Applicant Depuy, Inc.

K number K914695

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KWT 1991-12-04

GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE

Applicant Depuy, Inc.

K number K914000

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KWT 1991-03-26

GLOBAL TOTAL SHOULDER

Applicant Depuy, Inc.

K number K905786

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KWT 1989-12-27

NON CONSTRAINED TOTAL SHOULDER SYSTEM

Applicant Orthopaedic Medical Group, Inc.

K number K895802

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KWT 1987-10-15

NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS

Applicant Kirschner Medical Corp.

K number K873621

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KWT 1987-10-15

NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.

Applicant Kirschner Medical Corp.

K number K873620

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KWT 1987-10-15

NEER-III GLENOID RESURFACING PROSTHESIS

Applicant Kirschner Medical Corp.

K number K873104

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KWT 1987-08-27

BIOMET MODULAR SHOULDER PROSTHESIS

Applicant Biomet, Inc.

K number K872454

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KWT 1983-11-07

MONOSPHERICAL RESURFACING GLENOID PROS

Applicant Howmedica Corp.

K number K833409

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KWT 1983-06-03

GLENOID RESURFACING COMPONENT-3M-10816

Applicant 3M Company

K number K831233

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KWT 1983-06-02

GLENOID RESURFACE COMPONENT PMN 3M

Applicant 3M Company

K number K831234

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KWT 1980-12-01

GRISTINA GLENOID PROSTHESIS

Applicant Howmedica Corp.

K number K802124

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KWT 1979-06-22

ZIMMER R TOTAL SHOULDER II

Applicant Zimmer, Inc.

K number K790987

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