Panels › Orthopedic › Product code PKC · Class 2
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Regulation 888.3660
2510(k)s in 12 months (20 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PKC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K262955 | OsseoFit Stemless Shoulder System Zimmer, Inc. | PKC |
| May 1, 2026 | K254154 | FX V135 EASYTECH® Shoulder System FX Shoulder Solutions, Inc. | PKC |
| Oct 3, 2025 | K252129 | AETOS Shoulder System Stemless Humeral Prosthesis Smith & Nephew, Inc. | PKC |
| Dec 23, 2024 | K243248 | INHANCE INTACT Depuy Ireland UC, IE | PKC |
| Dec 11, 2024 | K241873 | OsseoFit Stemless Shoulder System Zimmer, Inc. | PKC |
| Nov 20, 2024 | K240716 | AETOS Shoulder System Stemless Humeral Prosthesis Smith & Nephew, Inc. | PKC |
| Mar 17, 2023 | K221758 | SMR Stemless Anatomic Lima Corporate S.P.A., IT | PKC |
| Sep 14, 2022 | K220418 | Tornier Perform Humeral System Stemless Tornier, Inc. | PKC |
| Mar 11, 2022 | K213615 | Shoulder Innovations Total Shoulder System Shoulder Innovations, Inc. | PKC |
| Jan 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System Depuy(Ireland), IE | PKC |
| Jul 16, 2021 | K203108 | Ignite Stemless Anatomic Shoulder System Ignite Orthopedics, LLC | PKC |
| Feb 16, 2021 | K201391 | Easytech® Anatomical Shoulder System Fx Shoulder USA, Inc. | PKC |
| Nov 20, 2020 | K203100 | Arthrex Eclipse Titanium Humeral Head Arthrex, Inc. | PKC |
| Jul 8, 2020 | K201542 | Arthrex Eclipse Shoulder Prosthesis System Arthrex, Inc. | PKC |
| Jun 3, 2020 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder Encore Medical L.P. | PKC |
| Apr 29, 2020 | K192097 | Exactech® Equinoxe® Stemless Humeral Components Exactech, Inc. | PKC |
| Apr 22, 2019 | K182516 | Comprehensive Nano Stemless Shoulder Biomet Manufacturing Corp | PKC |
| Mar 9, 2018 | K173388 | Exactech Equinoxe Stemless Shoulder Exactech, Inc. | PKC |
| Dec 18, 2017 | K171858 | Sidus Stem-Free Shoulder Zimmer GmbH, CH | PKC |
| Mar 4, 2015 | K143552 | Simpliciti Shoulder System Tornier, Inc. | PKC |
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