Cleared Traditional

Catalyst EA Convertible Stemmed Shoulder

K222317 · Catalyst Orthoscience, Inc. · Orthopedic

Nov 2022

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K222317 is an FDA 510(k) clearance for the Catalyst EA Convertible Stemmed Shoulder, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on November 10, 2022, 100 days after receiving the submission on August 2, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K222317 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2022
Decision Date	November 10, 2022
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660