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FDA 510(k)

NextStep Arthropedix Total Knee System

K-Number: K242410 · 2025-05-08

ApplicantNextstep Arthropedix
Decision Date2025-05-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NextStep Arthropedix Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Nextstep Arthropedix. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K242410. 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 NextStep Arthropedix Total Knee System?

NextStep Arthropedix Total Knee System is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Nextstep Arthropedix. The 510(k) number is K242410.

When did NextStep Arthropedix Total Knee System receive FDA 510(k) clearance?

NextStep Arthropedix Total Knee System received FDA 510(k) clearance on 2025-05-08, under 510(k) number K242410.

Who is the listed applicant for NextStep Arthropedix Total Knee System?

The FDA 510(k) record lists Nextstep Arthropedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextStep Arthropedix Total Knee System?

The FDA product code for NextStep Arthropedix Total Knee System is JWH.

Other records listing Nextstep Arthropedix 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.

K241875TheRay Collared and Collarless Femoral Stem

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

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

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