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ROSA Shoulder System

by Orthosoft Inc. (d/b/a) Zimmer CAS 2 variants

510(k) K233199

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) K233199↗

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 NumberK233199 Date21 Feb 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  • Withdrawn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
FDA applicant
Orthosoft Inc (D/B/A Zimmer Cas)
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 Shoulder System is a stereotactic surgical instrument designed for precise, image-guided orthopaedic procedures. It integrates robotic-assisted technology to enhance accuracy in shoulder joint surgeries, including arthroplasty and fracture fixation, by providing real-time navigation and alignment guidance.

This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). It operates in sterile surgical environments and is classified under product codes OLO and LLZ, adhering to regulatory standards for Class II devices. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.

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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® Shoulder System different from traditional shoulder surgery tools, and what specific procedures does it support?

    The ROSA® Shoulder System integrates robotic-assisted technology to provide real-time navigation and alignment guidance, improving precision during shoulder surgeries. It is specifically designed for procedures like shoulder arthroplasty (replacement) and fracture fixation, offering enhanced accuracy compared to conventional instruments by leveraging stereotactic imaging and robotic assistance.

  • Is the ROSA® Shoulder System intended for single-use or reusable applications, and how should it be handled to maintain sterility?

    The ROSA® Shoulder System is supplied as a reusable medical device, meaning it is designed for multiple uses after proper cleaning, disinfection, and sterilization. Since it operates in sterile surgical environments, strict adherence to the manufacturer’s storage and handling guidelines is required to preserve sterility and functionality between procedures.

  • What regulatory pathways does the ROSA® Shoulder System follow, and how does this affect its availability in different markets?

    The ROSA® Shoulder System is cleared under FDA 510(k) in the U.S. and complies with the EU Medical Device Regulation (MDR) for European markets. These pathways ensure it meets stringent safety and performance standards before commercial distribution, allowing it to be legally marketed in both regions under their respective regulatory frameworks.

  • Does the ROSA® Shoulder System require any special storage conditions, and how should it be prepared for use in the operating room?

    While specific storage conditions are outlined in the manufacturer’s guidelines, the system is designed for use in sterile surgical environments. Proper cleaning, disinfection, and sterilization procedures must be followed between uses to maintain its functionality and compliance with regulatory standards for reusable medical devices.