DeviceClearance

NEXUS® Hip Stem— 510(k) K262473

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K262473 for NEXUS® Hip Stem, Substantially Equivalent on 2026-10-01. Applicant: Microport Orthopedics, Inc.. Device class: 2.

Summary

The NEXUS Hip Stem from Microport Orthopedics is filed under LZO, semi-constrained metal/ceramic/polymer hip prostheses, cemented or non-porous uncemented.

Class II, 21 CFR 888.3353. The Orthopedic panel reviewed it as a Special 510(k).

Microport Orthopedics filed from Arlington, Tennessee. Review took 76 days (July 17 to October 1, 2026).

Clearance details

Applicant
Microport Orthopedics, Inc.
Product code
Product code LZO
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Arlington, TN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.