Cleared Traditional

K252418 - Catalyst F1x Shoulder System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 189
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K252418.
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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
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K230513 · Arthrex, Inc. · Sep 2023