Cleared Traditional

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

K210861 · Stryker GmbH · Orthopedic

Sep 2021

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K210861 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 September 3, 2021, 164 days after receiving the submission on March 23, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K210861 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2021
Decision Date	September 03, 2021
Days to Decision	164 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