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FDA 510(k)

Catalyst F1x Shoulder System

K-Number: K252418 · 2025-11-06

ApplicantCatalyst Orthoscience, Inc.
Decision Date2025-11-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst F1x Shoulder System is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2025-11-06 under approval number K252418. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst F1x Shoulder System?

Catalyst F1x Shoulder System is a medical device that received FDA 510(k) clearance on 2025-11-06. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K252418.

When was Catalyst F1x Shoulder System approved by the FDA?

Catalyst F1x Shoulder System received FDA 510(k) clearance on 2025-11-06, under approval number K252418.

What company makes Catalyst F1x Shoulder System?

Catalyst F1x Shoulder System is manufactured by Catalyst Orthoscience, Inc..

What is the FDA product code for Catalyst F1x Shoulder System?

The FDA product code for Catalyst F1x Shoulder System is KWS.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Catalyst Orthoscience, Inc.

K181287Catalyst CSR Shoulder System K173812Catalyst CSR 3 Peg Glenoids K191811Catalyst OrthoScience CSR Shoulder System K182500Catalyst CSR Press-Fit Humeral Components K211991Catalyst R1 Reverse Shoulder System K202611Catalyst OrthoScience R1 Reverse Shoulder System

View all 12 devices →

Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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