Cleared Special

Catalyst OrthoScience CSR Shoulder System (K191811) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191811 · Catalyst Orthoscience, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
68d
Days
Class 2
Risk

K191811 is an FDA 510(k) clearance for the Catalyst OrthoScience CSR Shoulder System. 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 September 11, 2019 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Catalyst Orthoscience, Inc. devices

Submission Details

510(k) Number K191811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2019
Decision Date September 11, 2019
Days to Decision 68 days
Submission Type Special
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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 K191811.
LINK Embrace Shoulder System- Anatomical Configuration
K210899 · Waldemar Link GmbH & Co. KG · Jun 2021
TiN Coated Humeral Head
K191698 · Fx Shoulder USA, Inc. · Jul 2020
Shoulder Innovations Total Shoulder System
K192365 · Shoulder Innovations, Inc. · Nov 2019
Signature ONE System
K190595 · Orthosoft Inc. (d/b/a) Zimmer CAS · Jun 2019
Catalyst CSR Press-Fit Humeral Components
K182500 · Catalyst Orthoscience, Inc. · Jan 2019
Catalyst CSR Shoulder System
K181287 · Catalyst Orthoscience, Inc. · Jul 2018