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FDA 510(k)

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

K-Number: K243574 · 2025-02-18

ApplicantMicroport Orthopedics, Inc.
Decision Date2025-02-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-02-18 under 510(k) number K243574. 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 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique?

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique is a medical device that received FDA 510(k) clearance on 2025-02-18. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K243574.

When did Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique receive FDA 510(k) clearance?

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique received FDA 510(k) clearance on 2025-02-18, under 510(k) number K243574.

Who is the listed applicant for Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique?

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

What is the FDA product code for Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique?

The FDA product code for Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique is JWH.

Related Clinical Trials

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.

NCT06158646Mechanically or Kinematically Aligned Total Knee ProsthesisRECRUITINGNCT07533188Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert TypesRECRUITING

Other records listing Microport Orthopedics, 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.

K250444NEXUS® Hip StemK240046Ethylene Oxide Sterilization Supplier Change for MPO HipsK240452Ceramic Femoral HeadK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseK233507EVOLUTION® Tibial ConesK231947EVOLUTION® Cement Keel

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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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