Cleared Traditional

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

K202289 · Stryker GmbH · Orthopedic

Dec 2020

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K202289 is an FDA 510(k) clearance for the ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA), a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on December 16, 2020, 126 days after receiving the submission on August 12, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K202289 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2020
Decision Date	December 16, 2020
Days to Decision	126 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