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ROSA Knee System

by Orthosoft D/B/A Zimmer Cas 2 variants

510(k) K221928

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) K221928↗

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 · Traditional NumberK221928 Date4 Oct 2022ClearedStatusActive
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  • Withdrawn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 stereotaxic instrumentation system classified as a surgical navigation device for total knee arthroplasty (TKA). It provides software-defined spatial boundaries and reference information to assist surgeons in accurately identifying anatomical structures during knee implant placement, enhancing precision in bone resections and soft tissue assessment.

This system is used intraoperatively in orthopedic surgery settings to support total knee replacement procedures. Supplied as a reusable device, it requires sterile preparation for each use and is regulated under FDA 510(k) clearance (K221928) and the EU Medical Device Regulation (MDR). Compatible with standard operating room environments, it is designed for use with Zimmer Biomet’s knee implant systems and adheres to the OLO product code classification.

Other devices from Orthosoft Inc. (d/b/a) Zimmer CAS

See all devices from Orthosoft Inc. (d/b/a) Zimmer CAS →

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.

  • What types of knee procedures is the ROSA® Knee System designed to assist with during surgery?

    The ROSA® Knee System is specifically designed to assist surgeons in total knee arthroplasty (TKA), also known as total knee replacement. It provides spatial reference information and software-defined boundaries to help with precise identification of anatomical landmarks, ensuring accurate bone resections and soft tissue assessment during the procedure.

  • Is the ROSA® Knee System reusable, and how should it be prepared for each use?

    Yes, the ROSA® Knee System is a reusable device. Since it is used intraoperatively, it must undergo sterile preparation before each surgical procedure to maintain infection control standards. This ensures safety and compliance with medical device regulations.

  • Which knee implant systems is the ROSA® Knee System compatible with, and where is it primarily used?

    The ROSA® Knee System is designed for use with Zimmer Biomet’s knee implant systems and is intended for orthopedic surgery settings, specifically operating rooms where total knee replacements are performed. Its software and instrumentation integrate with these implants to enhance precision during TKA procedures.

  • How is the regulatory status of the ROSA® Knee System determined, and what does that mean for its use?

    The ROSA® Knee System holds FDA 510(k) clearance (K221928) and complies with the EU Medical Device Regulation (MDR). This means it has undergone review by regulatory authorities to confirm it is substantially equivalent to a previously cleared device (as per the FDA’s decision) and meets safety and performance requirements for surgical navigation in total knee arthroplasty, allowing its use in approved medical environments.