PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II
FDA product code PKC covers "Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained", a Class II medical device regulated under 21 CFR 888.3660. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 19 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254154 | fx shoulder solutions | FX V135 EASYTECH® Shoulder System | May 1, 2026 |
| K252129 | smith and nephew | AETOS Shoulder System Stemless Humeral Prosthesis | October 3, 2025 |
| K243248 | depuy ireland uc | INHANCE INTACT | December 23, 2024 |
| K241873 | zimmer | OsseoFit Stemless Shoulder System | December 11, 2024 |
| K240716 | smith and nephew | AETOS Shoulder System Stemless Humeral Prosthesis | November 20, 2024 |
| K221758 | lima corporate | SMR Stemless Anatomic | March 17, 2023 |
| K220418 | tornier | Tornier Perform Humeral System Stemless | September 14, 2022 |
| K213615 | shoulder innovations | Shoulder Innovations Total Shoulder System | March 11, 2022 |
| K212683 | depuy(ireland) | GLOBAL ICON Stemless Shoulder System | January 19, 2022 |
| K203108 | ignite orthopedics | Ignite Stemless Anatomic Shoulder System | July 16, 2021 |
| K201391 | fx shoulder usa | Easytech® Anatomical Shoulder System | February 16, 2021 |
| K203100 | arthrex | Arthrex Eclipse Titanium Humeral Head | November 20, 2020 |
| K201542 | arthrex | Arthrex Eclipse Shoulder Prosthesis System | July 8, 2020 |
| K193226 | encore medical l.p | AltiVate Anatomic Canal-Sparing (CS) Shoulder | June 3, 2020 |
| K192097 | exactech | Exactech® Equinoxe® Stemless Humeral Components | April 29, 2020 |
| K182516 | biomet manufacturing | Comprehensive Nano Stemless Shoulder | April 22, 2019 |
| K173388 | exactech | Exactech Equinoxe Stemless Shoulder | March 9, 2018 |
| K171858 | zimmer | Sidus Stem-Free Shoulder | December 18, 2017 |
| K143552 | tornier | Simpliciti Shoulder System | March 4, 2015 |