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FDA 510(k)

KeYi Total Knee System

K-Number: K230120 · 2024-04-19

ApplicantBeijing Keyi Medical Device Technology Co., Ltd.
Decision Date2024-04-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KeYi Total Knee System is a medical device manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-19 under approval number K230120. 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 KeYi Total Knee System?

KeYi Total Knee System is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K230120.

When was KeYi Total Knee System approved by the FDA?

KeYi Total Knee System received FDA 510(k) clearance on 2024-04-19, under approval number K230120.

What company makes KeYi Total Knee System?

KeYi Total Knee System is manufactured by Beijing Keyi Medical Device Technology Co., Ltd..

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

The FDA product code for KeYi 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)

Other Devices by Beijing Keyi Medical Device Technology Co., Ltd.

K162380Locking Plate System K190567KeYi Spinal Fixation System K191826KeYi Total Hip System

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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