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FDA 510(k)

ROSA Partial Knee System

K-Number: K210121 · 2021-04-19

ApplicantOrthosoft D/B/A Zimmer Cas
Decision Date2021-04-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA Partial Knee System is a medical device manufactured by Orthosoft D/B/A Zimmer Cas. It received FDA 510(k) clearance on 2021-04-19 under approval number K210121. 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 Partial Knee System?

ROSA Partial Knee System is a medical device that received FDA 510(k) clearance on 2021-04-19. It is manufactured by Orthosoft D/B/A Zimmer Cas. The 510(k) number is K210121.

When was ROSA Partial Knee System approved by the FDA?

ROSA Partial Knee System received FDA 510(k) clearance on 2021-04-19, under approval number K210121.

What company makes ROSA Partial Knee System?

ROSA Partial Knee System is manufactured by Orthosoft D/B/A Zimmer Cas.

What is the FDA product code for ROSA Partial Knee System?

The FDA product code for ROSA Partial Knee System is OLO.

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Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Orthosoft D/B/A Zimmer Cas

K210998ROSA Hip System K210653ONE Planner Hip K221928ROSA® Knee System K213033iASSIST Knee System K232533ROSA Partial Knee System K230243ROSA® Knee System

View all 7 devices →

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

View on FDA Database →

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

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