Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA product code KWS · 176 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3660
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1980-12-31 – 2026-07-22
KWS
2007-06-29
KWS
2006-12-11
MODULAR HYBRID GLENOID
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KWS
2006-12-06
TOTAL AND HEMI SHOULDER SYSTEM
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KWS
2006-10-31
ANATOMICAL SHOULDER FRACTURE SYSTEM
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KWS
2006-10-03
SOLAR REUNION FRACTURE STEM
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KWS
2006-06-28
DEPUY GLOBAL AP SHOULDER SYSTEM
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KWS
2006-03-02
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
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KWS
2005-10-06
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
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KWS
2005-07-19
ANATOMICAL SHOULDER KEELED GLENOID
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KWS
2005-01-31
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
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KWS
2004-12-17
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
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KWS
2004-11-23
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
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KWS
2004-10-26
EXACTECH EQUINOXE SHOULDER SYSTEM
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KWS
2004-06-17
AEQUALIS SHOULDER SYSTEM
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KWS
2004-06-04
VERSA-DIAL HUMERAL HEAD
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KWS
2004-02-02
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
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KWS
2003-12-15
AEQUALIS SHOULDER FRACTURE SYSTEM
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KWS
2003-09-23
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
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KWS
2003-04-24
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
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KWS
2003-03-04
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
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KWS
2002-09-06
ARTHREX UNIVERS FRACTURE PROSTHESIS
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KWS
2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
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KWS
2001-12-13
3D HUMERAL HEADS
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KWS
2001-12-06
PLASMA SPRAYED SHOULDER
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KWS
2001-08-15
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
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KWS
2001-04-06
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
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KWS
2001-02-28
ANATOMICAL PRESS-FIT HUMERAL STEM
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KWS
2001-02-14
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
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KWS
2001-01-04
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
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KWS
2000-12-20
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
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KWS
2000-11-22
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
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KWS
2000-08-16
WMT MODULAR SHOULDER SYSTEM
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KWS
2000-06-22
AEQUALIS UNIVERSAL SHOULDER GLENOID
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KWS
2000-06-08
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
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KWS
2000-05-23
NEER III TOTAL SHOULDER SYSTEM
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KWS
2000-03-10
AEQUALIS SHOULDER FRACTURE SYSTEM
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KWS
2000-03-10
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
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KWS
1999-10-21
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
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KWS
1999-09-13
BIO-MODULAR SHOULDER SYSTEM
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KWS
1999-08-23
AEQUALIS SHOULDER PROSTHESIS
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KWS
1999-07-12
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
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KWS
1999-03-15
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
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KWS
1999-03-01
ANATOMICA GLENOID COMPONENT
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KWS
1999-02-18
ANATOMICA HUMERAL STEM/HEAD COMPONENTS
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KWS
1998-07-13
DEPUY GLOBAL SHOULDER GLENOID
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KWS
1998-01-22
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
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KWS
1997-08-07
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
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KWS
1996-08-28
SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
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KWS
1996-08-13
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
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KWS
1996-04-15
FOUNDATION GLENOID COMPONENT
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KWS
1996-04-09
OSTEONICS N2/VAC PACKAGING PROCESS
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KWS
1996-04-08
COFIED MODULAR SHOULDER SYSTEM
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KWS
1996-03-05
OSTEONICS SHOULDER HUMERAL COMPONENTS
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KWS
1995-09-27
AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
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KWS
1995-06-16
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
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KWS
1995-05-30
TOTAL SHOULDER PROSTHESIS
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KWS
1995-05-22
SELECT(R) SHOULDER ALL POLY GLENOID
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KWS
1994-10-31
DEPUY POROUS COATED GLOBAL SHOULDER
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KWS
1993-07-22
3M MODULAR SHOULDER SYSTEM
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KWS
1991-01-28
BUECHEL-PAPPAS HUMERAL STEM COMPONENT
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KWS
1991-01-28
BEUCHEL-PAPPAS GLENOID COMPONENT
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KWS
1990-11-20
OSTEONICS SR GLENOID COMPONENTS
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KWS
1990-09-20
NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
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KWS
1990-06-08
PAPILLOTOME
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KWS
1989-11-03
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
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KWS
1989-04-27
INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
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KWS
1988-11-10
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
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KWS
1988-08-30
NORMAL HUMERAL PROSTHESIS
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KWS
1988-08-29
INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
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KWS
1987-04-03
FENLIN II SHOULDER PROSTHESIS
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KWS
1986-09-02
OSTEONICS SHOULDER PROSTHESIS
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KWS
1986-03-26
COFIELD SHOULDER SYSTEM
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KWS
1985-12-16
LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM
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KWS
1985-01-10
COFIELD SHOULDER SYSTEM
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KWS
1983-11-07
MONOSPHERICAL GLENOID PROSTH. KEEL
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KWS
1980-12-31
UCLA SHOULDER
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