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FDA 510(k)

EVOLUTION NitrX Medial-Pivot Knee

K-Number: K182251 · 2019-05-16

ApplicantMircoport Orthopedics, Inc.
Decision Date2019-05-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION NitrX Medial-Pivot Knee is the device name listed in this FDA 510(k) record. The listed applicant is Mircoport Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K182251. 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 NitrX Medial-Pivot Knee?

EVOLUTION NitrX Medial-Pivot Knee is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Mircoport Orthopedics, Inc.. The 510(k) number is K182251.

When did EVOLUTION NitrX Medial-Pivot Knee receive FDA 510(k) clearance?

EVOLUTION NitrX Medial-Pivot Knee received FDA 510(k) clearance on 2019-05-16, under 510(k) number K182251.

Who is the listed applicant for EVOLUTION NitrX Medial-Pivot Knee?

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

What is the FDA product code for EVOLUTION NitrX Medial-Pivot Knee?

The FDA product code for EVOLUTION NitrX Medial-Pivot Knee 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.

NCT03391323Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes StudyCOMPLETEDNCT04103502In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKAWITHDRAWN

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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