Cleared Traditional

Catalyst F1x Shoulder System

K252418 · Catalyst Orthoscience, Inc. · Orthopedic

Nov 2025

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K252418 is an FDA 510(k) clearance for the Catalyst F1x Shoulder System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on November 6, 2025, 97 days after receiving the submission on August 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K252418 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2025
Decision Date	November 06, 2025
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660