TiN Coated Humeral Head
FDA 510(k) K191698 · Fx Shoulder USA, Inc.
510(k) numberK191698
Submission
- Device name
- TiN Coated Humeral Head
- Applicant
- Fx Shoulder USA, Inc.
Dallas, TX, US - Received
- June 25, 2019
- Decision date
- July 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | Shoulder Innovations, Inc. | 11/29/2019SE |
More from Shoulder Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240278 | Full Wedge Lateralized and Augmented BaseplatesPHX · Traditional | 05/15/2024SE |
| K223801 | FX V135(TM) Shoulder ProsthesisPHX · Traditional | 06/05/2023SE |
| K222936 | Humeris® 135 Shoulder SystemPHX · Traditional | 11/07/2022SE |
| K213117 | FX V135 Shoulder ProsthesisPHX · Traditional | 06/07/2022SE |
| K210790 | Lateralized and Augmented BaseplatesPHX · Traditional | 08/25/2021SE |
| K201391 | Easytech® Anatomical Shoulder SystemPKC · Traditional | 02/16/2021SE |
| K191146 | Humelock TiN Coated GlenospherePHX · Traditional | 07/15/2020SE |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o StabilityPHX · Traditional | 04/29/2020SE |
| K192799 | Glenoid Baseplate with ScrewPHX · Traditional | 02/21/2020SE |
| K192206 | 32mm Glenosphere and Humeral CupPHX · Traditional | 10/08/2019SE |
Questions and answers
When was TiN Coated Humeral Head cleared by the FDA?
TiN Coated Humeral Head (K191698) received a 510(k) decision of Substantially Equivalent on July 16, 2020, 387 days after the submission was received.
What is the product code of K191698?
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.