Cleared Special

ROSA? Knee System

K242864 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic

Oct 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K242864 is an FDA 510(k) clearance for the ROSA? Knee 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 October 18, 2024, 28 days after receiving the submission on September 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K242864 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2024
Decision Date	October 18, 2024
Days to Decision	28 days
Submission Type	Special
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.