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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 the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-01-13 under 510(k) 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. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K243295.

When did Initia Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Initia Knee System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Initia Knee System?

The FDA product code for Initia Knee System is JWH.

Other records listing Kyocera Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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