Cleared Traditional

Catalyst F1x Shoulder System (K234105) - FDA 510(k) Clearance

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

K234105 · Catalyst Orthoscience, Inc. · Orthopedic device
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Apr 2024
Decision
101d
Days
Class 2
Risk

K234105 is an FDA 510(k) clearance for the Catalyst F1x Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on April 5, 2024 after a review of 101 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 K234105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2023
Decision Date April 05, 2024
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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 - PHX Shoulder Prosthesis, Reverse Configuration

All 139
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K234105.
AltiVate Reverse® Glenoid
K233481 · Encore Medical, L.P. · May 2024
Full Wedge Lateralized and Augmented Baseplates
K240278 · Fx Shoulder USA, Inc. · May 2024
Augment Off-Axis Instrument System
K241043 · Fix Surgical · May 2024
Augment Off-Axis Instrument System
K233148 · Fix Surgical · Mar 2024
BLUEPRINT™ Patient Specific Instrumentation
K232265 · Tornier S.A.S. · Feb 2024
LINK Embrace Shoulder System - Reverse Configuration
K231445 · Waldemar Link GmbH & Co. KG · Nov 2023