FDA Product Code
FDA Product Code PKC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3660
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2026-09-24 | Special | PDF ↗ |
| K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | 2026-05-01 | Traditional | PDF ↗ |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2025-10-03 | Traditional | PDF ↗ |
| K243248 | INHANCE INTACT | Depuy Ireland UC | 2024-12-23 | Traditional | PDF ↗ |
| K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024-12-11 | Traditional | PDF ↗ |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024-11-20 | Traditional | PDF ↗ |
| K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | 2023-03-17 | Traditional | PDF ↗ |
| K220418 | Tornier Perform Humeral System Stemless | Tornier, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K213615 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2022-03-11 | Traditional | PDF ↗ |
| K212683 | GLOBAL ICON Stemless Shoulder System | Depuy(Ireland) | 2022-01-19 | Traditional | PDF ↗ |
| K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-07-16 | Traditional | PDF ↗ |
| K201391 | Easytech® Anatomical Shoulder System | Fx Shoulder USA, Inc. | 2021-02-16 | Traditional | PDF ↗ |
| K203100 | Arthrex Eclipse Titanium Humeral Head | Arthrex, Inc. | 2020-11-20 | Special | PDF ↗ |
| K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2020-07-08 | Special | PDF ↗ |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020-06-03 | Traditional | PDF ↗ |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. | 2020-04-29 | Traditional | PDF ↗ |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019-04-22 | Traditional | PDF ↗ |
| K173388 | Exactech Equinoxe Stemless Shoulder | Exactech, Inc. | 2018-03-09 | Traditional | PDF ↗ |
| K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017-12-18 | Traditional | PDF ↗ |
| K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015-03-04 | Traditional | PDF ↗ |
Product code PKC · Class II · Orthopedic. Data: openFDA.