Shoulder Innovations Total Shoulder System
FDA 510(k) K192365 · Shoulder Innovations, Inc.
510(k) numberK192365
Submission
- Device name
- Shoulder Innovations Total Shoulder System
- Applicant
- Shoulder Innovations, Inc.
Holland, MI, US - Received
- August 30, 2019
- Decision date
- November 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | Exactech, Inc. | 12/01/2025SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | Tornier, Inc. | 10/30/2025SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 03/10/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 02/16/2024SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | Biomet Orthopedics | 07/12/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | Implantcast GmbH | 09/28/2022SE |
| K210899 | LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional | Waldemar Link GmbH & Co. KG | 06/21/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
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 |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | 03/11/2022SE |
| K210533 | Inset Reverse Total Shoulder SystemPHX · Traditional | 08/20/2021SE |
| 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 (K192365) received a 510(k) decision of Substantially Equivalent on November 29, 2019, 91 days after the submission was received.
What is the product code of K192365?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.