Cleared Traditional

Catalyst R1 Reverse Shoulder System (K223655) - FDA 510(k) Clearance

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

K223655 · Catalyst Orthoscience, Inc. · Orthopedic device
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May 2023
Decision
154d
Days
Class 2
Risk

K223655 is an FDA 510(k) clearance for the Catalyst R1 Reverse 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 May 9, 2023 after a review of 154 days - an extended review cycle.

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 K223655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2022
Decision Date May 09, 2023
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
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 K223655.
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
K223833 · Exactech, Inc. · Sep 2023
ARROW Off-Centred Humeral Insert
K232226 · FH Industrie · Aug 2023
FX V135(TM) Shoulder Prosthesis
K223801 · Fx Shoulder USA, Inc. · Jun 2023
Arthrex Univers Revers Monoblock Stem Size 4/33
K230366 · Arthrex, Inc. · Apr 2023
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
K214001 · Biomet Manufacturing Corp · Mar 2023
INHANCETM Shoulder System – Humeral Stems and Stemless
K223211 · Depuy Ireland UC · Dec 2022