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KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class II

FDA Device Classification

Classification Details

Product Code
KWT
Device Class
Class II
Regulation Number
888.3650
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250713exactechEquinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantDecember 1, 2025
K251686tornierTornier Humeral Reconstruction System Max (Tornier HRS Max)October 30, 2025
K241944implantcastAGILON® XO Shoulder Replacement SystemMarch 10, 2025
K241817shoulder innovationsInSet Total Shoulder SystemFebruary 11, 2025
K231657implantcastAGILON® XO Shoulder Replacement SystemFebruary 16, 2024
K223631biomet orthopedicsComprehensive Segmental Revision System(SRS)July 12, 2023
K222482implantcastAGILON XO Shoulder SystemSeptember 28, 2022
K210899waldemar link gmbh and co. kgLINK Embrace Shoulder System- Anatomical ConfigurationJune 21, 2021
K191698fx shoulder usaTiN Coated Humeral HeadJuly 16, 2020
K192365shoulder innovationsShoulder Innovations Total Shoulder SystemNovember 29, 2019
K191811catalyst orthoscienceCatalyst OrthoScience CSR Shoulder SystemSeptember 11, 2019
K190595orthosoft inc (d/b/a zimmer cas)Signature ONE SystemJune 5, 2019
K182500catalyst orthoscienceCatalyst CSR Press-Fit Humeral ComponentsJanuary 11, 2019
K181287catalyst orthoscienceCatalyst CSR Shoulder SystemJuly 12, 2018
K173812catalyst orthoscienceCatalyst CSR 3 Peg GlenoidsMarch 9, 2018
K162903exactechExactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesFebruary 27, 2017
K161476lima corporateSMR Shoulder SystemJune 24, 2016
K152825catalyst orthoscienceCatalyst CSR Shoulder SystemMay 11, 2016
K150730zimmerZimmer PSI Shoulder SystemJune 16, 2015
K143659exactechEquinoxe Mega ProsthesisApril 9, 2015