Cleared Traditional

Catalyst CSR Press-Fit Humeral Components (K182500) - FDA 510(k) Clearance

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

K182500 · Catalyst Orthoscience, Inc. · Orthopedic device
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Jan 2019
Decision
121d
Days
Class 2
Risk

K182500 is an FDA 510(k) clearance for the Catalyst CSR Press-Fit Humeral Components. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 121 days - within the typical 510(k) review window.

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, Inc. devices

Submission Details

510(k) Number K182500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2018
Decision Date January 11, 2019
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 42
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K182500.
Shoulder Innovations Total Shoulder System
K192365 · Shoulder Innovations, Inc. · Nov 2019
Catalyst OrthoScience CSR Shoulder System
K191811 · Catalyst Orthoscience, Inc. · Sep 2019
Signature ONE System
K190595 · Orthosoft Inc. (d/b/a) Zimmer CAS · Jun 2019
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