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FDA 510(k)

NEXUS® Hip Stem

K-Number: K250444 · 2025-05-15

ApplicantMicroport Orthopedics, Inc.
Decision Date2025-05-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXUS® Hip Stem is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-05-15 under approval number K250444. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXUS® Hip Stem?

NEXUS® Hip Stem is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K250444.

When was NEXUS® Hip Stem approved by the FDA?

NEXUS® Hip Stem received FDA 510(k) clearance on 2025-05-15, under approval number K250444.

What company makes NEXUS® Hip Stem?

NEXUS® Hip Stem is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for NEXUS® Hip Stem?

The FDA product code for NEXUS® Hip Stem is LZO.

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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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