Cleared Traditional

NEXUS? Hip Stem

K250444 · Microport Orthopedics, Inc. · Orthopedic
May 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250444 is an FDA 510(k) clearance for the NEXUS? Hip Stem, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on May 15, 2025, 90 days after receiving the submission on February 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K250444 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2025
Decision Date May 15, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3353

Similar Devices — LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 527
implaFit? short stems
K252401 · Implantcast GmbH · Mar 2026
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
K253171 · Maxx Orthopedics, Inc. · Jan 2026
Coated hip implants
K250450 · Medacta International S.A. · Sep 2025
Longboard Revision Hip Stem
K243021 · Signature Orthopaedics Pty, Ltd. · Aug 2025
Z1 Hip System
K251906 · Zimmer, Inc. · Jul 2025
RECLAIM Monobloc Revision Femoral Stem
K251292 · Depuy Ireland UC · May 2025

More from Microport Orthopedics, Inc.

View all
Evolution? Total Knee Systems - Kinematic Alignment Instrumentation and Technique
K243574 · JWH · Feb 2025
Ceramic Femoral Head
K240452 · LZO · Apr 2024
EVOLUTION? 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 Inse
K240043 · KRO · Apr 2024
EVOLUTION? Tibial Cones
K233507 · MBH · Jan 2024
EVOLUTION? Cement Keel
K231947 · JWH · Oct 2023