Shoulder Innovations Total Shoulder System
FDA 510(k) K213615 · Shoulder Innovations, Inc.
510(k) numberK213615
Submission
- Device name
- Shoulder Innovations Total Shoulder System
- Applicant
- Shoulder Innovations, Inc.
Holland, MI, US - Received
- November 15, 2021
- Decision date
- March 11, 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 |
| K212683 | GLOBAL ICON Stemless Shoulder SystemPKC · Traditional | Depuy(Ireland) | 01/19/2022SE |
| 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 |
|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | 09/08/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | 04/13/2026SE |
| K252516 | N22 EZ GlenospherePHX · Traditional | 01/15/2026SE |
| K252221 | Inset Reverse Total Shoulder SystemPHX · Traditional | 09/26/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | 02/11/2025SE |
| K210533 | Inset Reverse Total Shoulder SystemPHX · Traditional | 08/20/2021SE |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | 11/29/2019SE |
| K173824 | Humeral Short Stem SystemMBF · Traditional | 10/23/2018SE |
| K111596 | Total Shoulder SystemKWS · Special | 07/05/2011SE |
| K110905 | Total Shoulder SystemKWS · Special | 05/24/2011SE |
Questions and answers
When was Shoulder Innovations Total Shoulder System cleared by the FDA?
Shoulder Innovations Total Shoulder System (K213615) received a 510(k) decision of Substantially Equivalent on March 11, 2022, 116 days after the submission was received.
What is the product code of K213615?
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.