Catalyst F1x Shoulder System
FDA 510(k) K252418 · Catalyst Orthoscience, Inc.
510(k) numberK252418
Submission
- Device name
- Catalyst F1x Shoulder System
- Applicant
- Catalyst Orthoscience, Inc.
Naples, FL, US - Received
- August 1, 2025
- Decision date
- November 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
| K220847 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 01/03/2023SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K234105 | Catalyst F1x Shoulder SystemPHX · Traditional | 04/05/2024SE |
| K232583 | Catalyst R1 Reverse Shoulder SystemPHX · Special | 09/20/2023SE |
| K223655 | Catalyst R1 Reverse Shoulder SystemPHX · Traditional | 05/09/2023SE |
| K222317 | Catalyst EA Convertible Stemmed ShoulderKWS · Traditional | 11/10/2022SE |
| K213349 | Catalyst R1 Reverse Shoulder SystemPHX · Traditional | 06/23/2022SE |
| K211991 | Catalyst R1 Reverse Shoulder SystemPHX · Special | 07/28/2021SE |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder SystemPHX · Traditional | 02/12/2021SE |
| K191811 | Catalyst OrthoScience CSR Shoulder SystemKWT · Special | 09/11/2019SE |
| K182500 | Catalyst CSR Press-Fit Humeral ComponentsKWT · Traditional | 01/11/2019SE |
| K181287 | Catalyst CSR Shoulder SystemKWT · Special | 07/12/2018SE |
Questions and answers
When was Catalyst F1x Shoulder System cleared by the FDA?
Catalyst F1x Shoulder System (K252418) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 97 days after the submission was received.
What is the product code of K252418?
The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.