Cleared Traditional

K252418 - Catalyst F1x Shoulder System

K252418 is an FDA 510(k) clearance for Catalyst F1x Shoulder System, manufactured by Catalyst Orthoscience, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K252418 · Catalyst Orthoscience, Inc. · Orthopedic device
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Nov 2025
Decision
97d
Days
Class 2
Risk

K252418 is an FDA 510(k) clearance for the Catalyst F1x Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on November 6, 2025 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Catalyst Orthoscience, Inc. devices

FDA 510(k) Submission Details - K252418

510(k) Number K252418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 156
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K252418.
Tornier Perform Advanced Glenoid
K260721 · Tornier, Inc. · Jul 2026
AETOS Shoulder System - CONCELOC Glenoids
K254084 · Smith & Nephew, Inc. · Apr 2026
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · Smith & Nephew, Inc. · Oct 2025
MyShoulder Planner (5.3SSWPL)
K241292 · Medacta International S.A. · Jan 2025
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · Stryker Corporation (Tornier, Inc.) · Dec 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · Stryker Corporation (Tornier, Inc.) · Sep 2024