Cleared Traditional

K152825 - Catalyst CSR Shoulder System

K152825 is an FDA 510(k) clearance for Catalyst CSR Shoulder System, manufactured by Catalyst Orthoscience, LLC. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K152825 · Catalyst Orthoscience, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152825

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.

KWT Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K152825.
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
SMR Shoulder System
K161476 · Lima Corporate S.P.A. · Jun 2016
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