Cleared Traditional

Rosa? Knee System

K251314 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic

Nov 2025

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K251314 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 November 13, 2025, 199 days after receiving the submission on April 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K251314 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2025
Decision Date	November 13, 2025
Days to Decision	199 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.