Cleared Traditional

ROSA? Shoulder System

K233199 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic

Feb 2024

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K233199 is an FDA 510(k) clearance for the ROSA? Shoulder System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on February 21, 2024, 146 days after receiving the submission on September 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K233199 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	February 21, 2024
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.