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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 the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) 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. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K252418.

When did Catalyst F1x Shoulder System receive FDA 510(k) clearance?

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

Who is the listed applicant for Catalyst F1x Shoulder System?

The FDA 510(k) record lists Catalyst Orthoscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Catalyst Orthoscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234105Catalyst F1x Shoulder SystemK232583Catalyst R1 Reverse Shoulder SystemK223655Catalyst R1 Reverse Shoulder SystemK222317Catalyst EA Convertible Stemmed ShoulderK213349Catalyst R1 Reverse Shoulder SystemK211991Catalyst R1 Reverse Shoulder System

View all 13 devices →

Related Devices (Code: KWS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)

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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