PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar— 510(k) K200007

Name: FDA 510(k) clearance K200007
Creator: U.S. Food and Drug Administration
Published: 2020-04-25

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K200007 for PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar, Substantially Equivalent on 2020-04-25. Applicant: Microport Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Microport Orthopedics, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2020-01-02
Decision date: 2020-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

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K253948 — Momentum Acetabular Cup System2026-09-02
K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

More clearances from Microport Orthopedics, Inc.

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K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
K250444 — NEXUS® Hip Stem2025-05-15
K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique2025-02-18
K240452 — Ceramic Femoral Head2024-04-12
K240043 — EVOLUTION® Hinge Knee System +13 more2024-04-01

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.