Cleared Special

Catalyst CSR Shoulder System

K181287 · Catalyst Orthoscience, Inc. · Orthopedic

Jul 2018

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K181287 is an FDA 510(k) clearance for the Catalyst CSR Shoulder System, 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 July 12, 2018, 57 days after receiving the submission on May 16, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K181287 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2018
Decision Date	July 12, 2018
Days to Decision	57 days
Submission Type	Special
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