Cleared Traditional

Catalyst CSR Shoulder System (K152825) - FDA 510(k) Clearance

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

K152825 · Catalyst Orthoscience, LLC · Orthopedic device
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May 2016
Decision
225d
Days
Class 2
Risk

K152825 is an FDA 510(k) clearance for the Catalyst CSR Shoulder System. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Catalyst Orthoscience, LLC (Naples, US). The FDA issued a Cleared decision on May 11, 2016 after a review of 225 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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, LLC devices

Submission Details

510(k) Number K152825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date May 11, 2016
Days to Decision 225 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
103d slower than avg
Panel avg: 122d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 43
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K152825.
Catalyst CSR Shoulder System
K181287 · Catalyst Orthoscience, Inc. · Jul 2018
Catalyst CSR 3 Peg Glenoids
K173812 · Catalyst Orthoscience, Inc. · Mar 2018
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
K162903 · Exactech, Inc. · Feb 2017
Equinoxe Mega Prosthesis
K143659 · Exactech, Inc. · Apr 2015
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · Zimmer, Inc. · Oct 2012
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
K111746 · Biomet, Inc. · Dec 2011