Signature ONE System
FDA 510(k) K190595 · Orthosoft Inc (D/B/A Zimmer Cas)
510(k) numberK190595
Submission
- Device name
- Signature ONE System
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
Montreal, CA - Received
- March 7, 2019
- Decision date
- June 5, 2019
- 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 |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261510 | Signature ONE SystemQHE · Special | 06/04/2026SE |
| K260582 | ROSA® Shoulder SystemOLO · Traditional | 05/21/2026SE |
| K260104 | Signature ONE SystemQHE · Special | 02/04/2026SE |
| K251314 | Rosa® Knee SystemOLO · Traditional | 11/13/2025SE |
| K242864 | ROSA® Knee SystemOLO · Special | 10/18/2024SE |
| K233199 | ROSA® Shoulder SystemOLO · Traditional | 02/21/2024SE |
| K232425 | Signature ONE SystemQHE · Traditional | 12/12/2023SE |
| K230567 | OptiVu ROSA® MxRSBF · Traditional | 06/13/2023SE |
| K231162 | ROSA Hip SystemLLZ · Special | 05/23/2023SE |
| K230180 | Rosa Knee SystemOLO · Special | 02/22/2023SE |
Questions and answers
When was Signature ONE System cleared by the FDA?
Signature ONE System (K190595) received a 510(k) decision of Substantially Equivalent on June 5, 2019, 90 days after the submission was received.
What is the product code of K190595?
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.