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FDA 510(k)

SK Knee System

K-Number: K253961 · 2026-09-01

ApplicantJust Medical Devices (Tianjin) Co., Ltd.
Decision Date2026-09-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SK Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Just Medical Devices (Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K253961. 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 SK Knee System?

SK Knee System is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Just Medical Devices (Tianjin) Co., Ltd.. The 510(k) number is K253961.

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

SK Knee System received FDA 510(k) clearance on 2026-09-01, under 510(k) number K253961.

Who is the listed applicant for SK Knee System?

The FDA 510(k) record lists Just Medical Devices (Tianjin) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SK Knee System?

The FDA product code for SK Knee System is JWH.

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.

K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.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)NovoSource

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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