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PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II

FDA Device Classification

Classification Details

Product Code
PKC
Device Class
Class II
Regulation Number
888.3660
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

Replacement of the humeral head for total anatomic shoulder arthroplasty

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252129smith and nephewAETOS Shoulder System Stemless Humeral ProsthesisOctober 3, 2025
K243248depuy ireland ucINHANCE INTACT™December 23, 2024
K241873zimmerOsseoFit Stemless Shoulder SystemDecember 11, 2024
K240716smith and nephewAETOS Shoulder System Stemless Humeral ProsthesisNovember 20, 2024
K221758lima corporateSMR Stemless AnatomicMarch 17, 2023
K220418tornierTornier Perform Humeral System – StemlessSeptember 14, 2022
K213615shoulder innovationsShoulder Innovations Total Shoulder SystemMarch 11, 2022
K212683depuy(ireland)GLOBAL ICON Stemless Shoulder SystemJanuary 19, 2022
K203108ignite orthopedicsIgnite Stemless Anatomic Shoulder SystemJuly 16, 2021
K201391fx shoulder usaEasytech® Anatomical Shoulder SystemFebruary 16, 2021
K203100arthrexArthrex Eclipse Titanium Humeral HeadNovember 20, 2020
K201542arthrexArthrex Eclipse Shoulder Prosthesis SystemJuly 8, 2020
K193226encore medical, l.pAltiVate Anatomic Canal-Sparing (CS) ShoulderJune 3, 2020
K192097exactechExactech® Equinoxe® Stemless Humeral ComponentsApril 29, 2020
K182516biomet manufacturingComprehensive Nano Stemless ShoulderApril 22, 2019
K173388exactechExactech Equinoxe Stemless ShoulderMarch 9, 2018
K171858zimmerSidus Stem-Free ShoulderDecember 18, 2017
K143552tornierSimpliciti Shoulder SystemMarch 4, 2015