FDA 510(k)

Rosa® Knee System

K-Number: K251314 · 2025-11-13

ApplicantOrthosoft Inc. (d/b/a) Zimmer CAS

Decision Date2025-11-13

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Rosa® Knee System is a medical device manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS. It received FDA 510(k) clearance on 2025-11-13 under approval number K251314. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rosa® Knee System?

Rosa® Knee System is a medical device that received FDA 510(k) clearance on 2025-11-13. It is manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS. The 510(k) number is K251314.

When was Rosa® Knee System approved by the FDA?

Rosa® Knee System received FDA 510(k) clearance on 2025-11-13, under approval number K251314.

What company makes Rosa® Knee System?

Rosa® Knee System is manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS.

What is the FDA product code for Rosa® Knee System?

The FDA product code for Rosa® Knee System is OLO.

Other Devices by Orthosoft Inc. (d/b/a) Zimmer CAS

K242864ROSA® Knee System K260104Signature ONE System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.