Product Code: KWS


Products Classified as KWS

4577Prosthesis, Shoulder, Semi-constrained, Metal/polymer CementedShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4577Prosthesis, Shoulder, Semi-constrained, Metal/polymer CementedShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [34059]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [38231]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37410]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37411]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37435]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [35610]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37433]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37816]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [33508]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37831]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [32210]21 CFR §888.3660 🔎
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented [37814]21 CFR §888.3660 🔎

Pre-market Notifications for KWS

K222317Catalyst EA Convertible Stemmed ShoulderCatalyst OrthoScience, Inc.
K213827TITAN 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)Smith & Nephew, Inc.
K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimaCorporate
K213387AltiVate® Anatomic Shoulder AG E+™ With MarkersEncore Medical, L.P.
K212435Comprehensive Humeral Fracture Positioning SleevesBiomet Inc.
K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.
K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)Stryker GmbH
K203315BLUEPRINT™ Patient Specific InstrumentationTornier SAS
K203230Global Shoulder And Delta CTA SystemsDePuy Lnc.
K203026AltiVate® Anatomic Pegged Glenoid With MarkersEncore Medical, L.P.
K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)Stryker GmbH
K193180Alliance Augmented GlenoidZimmer Inc.
K191814Alliance GlenoidZimmer Inc.
K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.
K191247SmartSPACE Shoulder SystemTechMah Medical LLC

Global Unique Device Identification Database

00814193025524Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025517Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025500Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025494Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025487Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025432Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025425Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025418Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025401Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025395Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025388Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025371Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025364Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025357Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
00814193025340Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Maude Adverse Events

UNK HEADZIMMER BIOMET, INC.2020-03-31
FOUNDATION SHOULDERENCORE MEDICAL L.P.2020-03-31
ALTIVATE REVERSE SHOULDERENCORE MEDICAL L.P.2020-03-31
TURON SHOULDERENCORE MEDICAL L.P.2020-03-31
LINER F.MET.BACK GLEN.STANDARDLIMACORPORATE S.P.A.2020-03-31
UNK GLENOSPHEREZIMMER BIOMET, INC.2020-03-31
UNK BEARINGZIMMER BIOMET, INC.2020-03-31
UNK ZIMMER TM GLENOIDZIMMER BIOMET, INC.2020-03-30
AEQUALIS FLEX REVIVETORNIER INC2020-03-30
SIDUS HUMERAL HEAD EXTREMITIES IMPL WIN GENZIMMER GMBH2020-03-28
GLOBAL UNITE HEAD 56X21 ECCDEPUY ORTHOPAEDICS INC US2020-03-26
AEQUALIS ASCEND FLEX HUMERAL STEM2020-03-26
AEQUALIS ASCEND FLEX REVERSED INSERT2020-03-26
AEQUALIS ASCEND FLEX REVERSED TRAY2020-03-26
AEQUALIS REVERSED II BASEPLATE2020-03-26
AEQUALIS REVERSED II GLENOID SPHERE2020-03-26
DXTEND MOD CENT EPI 1 HADEPUY FRANCE SAS - 30038955752020-03-25
GLOBAL UNITE HEAD 52X15 ECCDEPUY ORTHOPAEDICS INC US2020-03-25
CROSSLINK ANCHOR PG GLENOID 52DEPUY ORTHOPAEDICS INC US2020-03-25
GLBL UNITE ANT BODY 135 SZ 14DEPUY ORTHOPAEDICS INC US2020-03-25
DXTEND STAND PE CUP D42 +3MMDEPUY FRANCE SAS - 30038955752020-03-25
EXTENDIBLE TOTAL HUMERAL REPLACEMENT - MINIMALLY INVASIVE GROWERSTANMORE IMPLANTS WORLDWIDE2020-03-25
DXTEND MODULAR HUM STEM D10 HADEPUY FRANCE SAS - 30038955752020-03-24
METAGLENE LONG PEG +10MMDEPUY FRANCE SAS - 30038955752020-03-23
LG HYBRID GLENOID BASE 4MMZIMMER BIOMET, INC.2020-03-23
VERSA-DIAL 50X21X57 HUM HEADZIMMER BIOMET, INC.2020-03-23
4.5MM PERIPHERAL SCREW - 32MMSTRYKER GMBH2020-03-20
4.5MM PERIPHERAL SCREW - 24MMSTRYKER GMBH2020-03-20
4.5MM PERIPHERAL SCREW - 32MMSTRYKER GMBH2020-03-20
4.5MM PERIPHERAL SCREW - 24MMSTRYKER GMBH2020-03-20
REUNION TSA - PRESS-FIT HUMERAL STEM 15MMSTRYKER GMBH2020-03-20
GLENOSPHERE - 36MM DIA X 6MM THK CONCENTRICSTRYKER GMBH2020-03-20
HUMERAL CUP - 36MM DIA X 4MM THKSTRYKER GMBH2020-03-20
UNKNOWN HEADZIMMER BIOMET, INC.2020-03-20
UNKNOWN STEMZIMMER BIOMET, INC.2020-03-20
COMP RVRS 25MM BSPLT HA+ADPTRZIMMER BIOMET, INC.2020-03-20
ALTIVATE REVERSE SHOULDERENCORE MEDICAL L.P2020-03-19
COMP RVRS 25MM BSPLT HA+ADPTRZIMMER BIOMET, INC.2020-03-18
GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRICSTRYKER GMBH2020-03-17
COMPR RVS GLENO 2-PRNG INS/IMPZIMMER BIOMET, INC.2020-03-17
ALTIVATE ANATOMIC SHOULDERENCORE MEDICAL L.P.2020-03-17
COMPR RVS GLENO 2-PRNG INS/IMPZIMMER BIOMET, INC.2020-03-17
COMP LK SCR 3.5HEX 4.75X30 STZIMMER BIOMET, INC.2020-03-16
COMP RVS CNTRL 6.5X35MM ST/RSTZIMMER BIOMET, INC.2020-03-16
COMP LK SCR 3.5HEX 4.75X25 STZIMMER BIOMET, INC.2020-03-16
COMP LK SCR 3.5HEX 4.75X20 STZIMMER BIOMET, INC.2020-03-16
COMP LK SCR 3.5HEX 4.75X30 STZIMMER BIOMET, INC.2020-03-16
ALTIVATE ANATOMIC SHOULDERENCORE MEDICAL L.P.2020-03-16
DXTEND RETENT PE CUP D42 +6MMDEPUY FRANCE SAS - 30038955752020-03-16
GLENOSPHERE HOLDER/ IMPA CTORSTRYKER GMBH2020-03-14
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