GLOBAL ICON Stemless Shoulder System
FDA 510(k) K212683 · Depuy(Ireland)
510(k) numberK212683
Submission
- Device name
- GLOBAL ICON Stemless Shoulder System
- Applicant
- Depuy(Ireland)
Cork, IE - Received
- August 24, 2021
- Decision date
- January 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Replacement of the humeral head for total anatomic shoulder arthroplasty
Other 510(k)s with product code PKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254154 | FX V135 EASYTECH® Shoulder SystemPKC · Traditional | FX Shoulder Solutions, Inc. | 05/01/2026SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 10/03/2025SE |
| K243248 | Inhance IntactPKC · Traditional | Depuy Ireland UC | 12/23/2024SE |
| K241873 | OsseoFit Stemless Shoulder SystemPKC · Traditional | Zimmer, Inc. | 12/11/2024SE |
| K240716 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 11/20/2024SE |
| K221758 | SMR Stemless AnatomicPKC · Traditional | Lima Corporate S.P.A. | 03/17/2023SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | Tornier, Inc. | 09/14/2022SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | Shoulder Innovations, Inc. | 03/11/2022SE |
| K203108 | Ignite Stemless Anatomic Shoulder SystemPKC · Traditional | Ignite Orthopedics, LLC | 07/16/2021SE |
| K201391 | Easytech® Anatomical Shoulder SystemPKC · Traditional | Fx Shoulder USA, Inc. | 02/16/2021SE |
More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192855 | DELTA XTEND(TM) Reverse Shoulder SystemPHX · Traditional | 02/24/2020SE |
| K190344 | DePuy Corail AMT Hip ProsthesisLZO · Traditional | 11/01/2019SE |
| K191779 | Attune Revision LPS InsertsKRO · Traditional | 10/08/2019SE |
| K192448 | Delta Xtend Revers Shoulder SystemPHX · Special | 10/04/2019SE |
| K183077 | Delta Xtend Reverse Shoulder SystemPHX · Traditional | 05/17/2019SE |
| K170806 | ATTUNE Cemented Tibial Base, Fixed BearingJWH · Traditional | 06/15/2017SE |
| K160907 | DePuy Actis DuoFix Hip ProsthesisMEH · Traditional | 07/19/2016SE |
| K160700 | ATTUNE Revision Knee SystemJWH · Traditional | 06/10/2016SE |
| K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsMBH · Traditional | 02/13/2015SE |
| K133834 | Depuy Global Unite Shoulder SystemKWS · Traditional | 04/03/2014SE |
Questions and answers
When was GLOBAL ICON Stemless Shoulder System cleared by the FDA?
GLOBAL ICON Stemless Shoulder System (K212683) received a 510(k) decision of Substantially Equivalent on January 19, 2022, 148 days after the submission was received.
What is the product code of K212683?
The FDA product code is PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3660.