Cleared Traditional

Catalyst CSR Press-Fit Humeral Components

K182500 · Catalyst Orthoscience, Inc. · Orthopedic

Jan 2019

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K182500 is an FDA 510(k) clearance for the Catalyst CSR Press-Fit Humeral Components, a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on January 11, 2019, 121 days after receiving the submission on September 12, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K182500 FDA.gov
FDA Decision	Cleared 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

Device Classification

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