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FDA 510(k)

MedalOne Total Knee System

K-Number: K244039 · 2025-02-28

ApplicantSuzhou Microport Orthorecon Co., Ltd.
Decision Date2025-02-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MedalOne Total Knee System is a medical device manufactured by Suzhou Microport Orthorecon Co., Ltd.. It received FDA 510(k) clearance on 2025-02-28 under approval number K244039. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedalOne Total Knee System?

MedalOne Total Knee System is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Suzhou Microport Orthorecon Co., Ltd.. The 510(k) number is K244039.

When was MedalOne Total Knee System approved by the FDA?

MedalOne Total Knee System received FDA 510(k) clearance on 2025-02-28, under approval number K244039.

What company makes MedalOne Total Knee System?

MedalOne Total Knee System is manufactured by Suzhou Microport Orthorecon Co., Ltd..

What is the FDA product code for MedalOne Total Knee System?

The FDA product code for MedalOne Total Knee System is JWH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: JWH)

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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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