FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K010869 |
ARGOMEDICAL AG |
EPOCA CUSTOM OFFSET SHOULDER SYSTEM |
10/11/2001 |
K042321 |
BIOMET MANUFACTURING CORP. |
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD |
01/28/2005 |
K223631 |
Biomet Orthopedics |
Comprehensive Segmental Revision System(SRS) |
07/12/2023 |
K020045 |
BIOMET ORTHOPEDICS, INC. |
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM |
01/30/2002 |
K023063 |
BIOMET ORTHOPEDICS, INC. |
COMPREHENSIVE HUMERAL FRACTURE SYSTEM |
12/13/2002 |
K030710 |
BIOMET, INC. |
BIO-MODULAR SHOULDER SYSTEM |
06/04/2003 |
K002998 |
BIOMET, INC. |
BIOMET BI-POLAR SHOULDER SYSTEM |
10/06/2000 |
K991585 |
BIOMET, INC. |
BIPOLAR SHOULDER PROSTHESIS |
08/18/1999 |
K961571 |
BIOMET, INC. |
COCR BI-ANGULAR HUMERAL COMPONENT |
08/05/1996 |
K111746 |
BIOMET, INC. |
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) |
12/15/2011 |
K043505 |
BIOMET, INC. |
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM |
02/09/2005 |
K032507 |
BIOMET, INC. |
INTERLOK BIO-MODULAR HUMERAL STEMS |
09/05/2003 |
K022079 |
BIOMET, INC. |
SHORT AND LONG SOFT TISSUE ATTACHMENT |
09/24/2002 |
K152825 |
CATALYST ORTHOSCIENCE LLC |
Catalyst CSR Shoulder System |
05/11/2016 |
K173812 |
Catalyst OrthoScience, Inc |
Catalyst CSR 3 Peg Glenoids |
03/09/2018 |
K182500 |
Catalyst OrthoScience, Inc. |
Catalyst CSR Press-Fit Humeral Components |
01/11/2019 |
K181287 |
Catalyst OrthoScience, Inc. |
Catalyst CSR Shoulder System |
07/12/2018 |
K191811 |
Catalyst OrthoScience, Inc. |
Catalyst OrthoScience CSR Shoulder System |
09/11/2019 |
K984541 |
DEPUY ORTHOPAEDICS, INC. |
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD |
01/14/1999 |
K991603 |
ENCORE ORTHOPEDICS, INC. |
GRIT BLASTED HUMERAL STEM |
06/29/1999 |
K960424 |
ENDOTEC, INC. |
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD |
08/26/1996 |
K162903 |
Exactech Inc |
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies |
02/27/2017 |
K143659 |
EXACTECH, INC. |
Equinoxe Mega Prosthesis |
04/09/2015 |
K110706 |
EXACTECH, INC. |
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD |
05/17/2011 |
K191698 |
FX Shoulder USA, Inc. |
TiN Coated Humeral Head |
07/16/2020 |
K123814 |
FX SOLUTIONS |
HUMELOCK II CEMENTED SHOULDER SYSTEM |
08/13/2013 |
K140071 |
FX SOLUTIONS |
HUMELOCK II CEMENTED SHOULDER SYSTEM |
07/28/2014 |
K222482 |
implantcast, GmbH |
AGILON XO Shoulder System |
09/28/2022 |
K022377 |
IMPLEX CORP. |
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 |
12/10/2002 |
K962315 |
INTERMEDICS ORTHOPEDICS |
SELECT SHOULDER COCR HUMERAL STEM COMPONENT |
09/03/1996 |
K970567 |
INTERMEDICS ORTHOPEDICS |
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS |
02/27/1997 |
K962238 |
INTERMEDICS ORTHOPEDICS |
SELECT SHOULDER KEELED ALL-POLY GLENOIDS |
08/09/1996 |
K962244 |
INTERMEDICS ORTHOPEDICS |
SELECT SHOULDER PEGGED ALL-POLY GLENOID |
08/09/1996 |
K100858 |
LIMA-LTO S.P.A. |
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, |
12/10/2010 |
K101263 |
LIMA-LTO S.P.A. |
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, |
01/28/2011 |
K161476 |
Limacorporate S.p.A. |
SMR Shoulder System |
06/24/2016 |
K071147 |
NEXA ORTHOPEDICS, INC. |
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM |
07/20/2007 |
K190595 |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Signature ONE System |
06/05/2019 |
K192365 |
Shoulder Innovations Inc |
Shoulder Innovations Total Shoulder System |
11/29/2019 |
K014049 |
STELKAST COMPANY |
EPOCA CODR STEM AND HEAD |
01/09/2002 |
K210899 |
Waldemar Link GmbH & Co. KG |
LINK Embrace Shoulder System- Anatomical Configuration |
06/21/2021 |
K150730 |
ZIMMER |
Zimmer PSI Shoulder System |
06/16/2015 |
K103404 |
ZIMMER GMBH |
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM |
03/15/2011 |
K110791 |
ZIMMER, INC. |
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION |
09/02/2011 |
K982981 |
ZIMMER, INC. |
NEW ZIMMER SHOULDER SYSTEM |
12/17/1998 |
K041549 |
ZIMMER, INC. |
ZIMMER TRABECULAR METAL HUMERAL STEM |
09/01/2004 |
K050761 |
ZIMMER, INC. |
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM |
04/11/2005 |
K121543 |
ZIMMER, INC. |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS |
10/11/2012 |