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FDA 510(k)

Initia Knee System

K-Number: K243295 · 2025-01-13

ApplicantKyocera Medical Technologies, Inc.
Decision Date2025-01-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Initia Knee System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-01-13 under approval number K243295. 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 Initia Knee System?

Initia Knee System is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K243295.

When was Initia Knee System approved by the FDA?

Initia Knee System received FDA 510(k) clearance on 2025-01-13, under approval number K243295.

What company makes Initia Knee System?

Initia Knee System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for Initia Knee System?

The FDA product code for Initia Knee System is JWH.

Other Devices by Kyocera Medical Technologies, Inc.

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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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