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ROSA Knee System

by Orthosoft D/B/A Zimmer Cas 2 variants

510(k) K230243

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK230243 Date29 Mar 2023ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 23 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 robotic surgical assistant device intended for use in knee arthroplasty procedures. It is designed to assist surgeons with preoperative planning and intraoperative guidance during total knee replacement surgery.

The device is supplied as a reusable system and is used in a hospital or surgical center setting. It has received FDA 510(k) clearance under K230243 and is classified under product code OLO. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

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