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ROSA Knee System

by Orthosoft Inc. (d/b/a) Zimmer CAS 3 variants

510(k) K242864

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242864↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK242864 Date18 Oct 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ROSA Knee System is a stereotactic instrumentation system classified as a Total Knee Arthroplasty Guidance Device (per FDA nomenclature). It provides software-defined spatial boundaries and reference information to assist surgeons in accurately positioning knee implant components during total knee replacement (TKA) surgery. By integrating anatomical landmarks and real-time imaging, it facilitates precise bone resections and soft tissue assessment to optimize implant alignment.

This system is used intraoperatively in orthopedic surgery settings and is supplied as a reusable device with FDA 510(k) clearance (K242864) and MDR compliance. It requires sterile handling and is designed for compatibility with standard operating room environments. No specific MRI safety classification is noted, and sizes or modular components are not detailed in the available data. Authorizations include regulatory submissions under the Orthopedic (OLO) product code, reviewed by the Orthopedic (OR) advisory committee.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • How is the ROSA® Knee System used during a total knee replacement procedure, and what does it help surgeons achieve?

    The ROSA® Knee System is an intraoperative stereotactic guidance tool designed to assist surgeons in total knee arthroplasty (TKA). It uses software-defined spatial boundaries and real-time anatomical landmarks to guide precise bone resections and soft tissue assessment. By providing reference information during surgery, it helps optimize the alignment and positioning of knee implant components, improving accuracy and potentially enhancing surgical outcomes.

  • Is the ROSA® Knee System reusable, and what considerations should be taken for its use in the operating room?

    Yes, the ROSA® Knee System is supplied as a reusable device. Since it requires sterile handling, it must be properly cleaned, disinfected, and sterilized between uses to maintain safety and functionality. It is designed for compatibility with standard operating room environments, ensuring it integrates smoothly into existing surgical workflows.

  • What regulatory pathways does the ROSA® Knee System follow, and which advisory committee was involved in its review?

    The ROSA® Knee System has undergone regulatory review through the FDA’s 510(k) clearance process (K242864) and is compliant with the EU’s Medical Device Regulation (MDR). Its submission was classified under the Orthopedic (OLO) product code and reviewed by the Orthopedic (OR) advisory committee, which specializes in orthopedic device evaluations.

  • Are there any specific safety notes regarding the use of the ROSA® Knee System in relation to MRI machines?

    The available data does not specify an MRI safety classification for the ROSA® Knee System. Clinicians should verify compatibility with their facility’s MRI protocols and ensure the device is not exposed to MRI environments unless explicitly confirmed safe for such use.