Ethylene Oxide Sterilization Supplier Change for MPO Hips— 510(k) K240046

Name: FDA 510(k) clearance K240046
Creator: U.S. Food and Drug Administration
Published: 2024-04-18

Substantially Equivalent

Microport Orthopedics

FDA 510(k) clearance K240046 for Ethylene Oxide Sterilization Supplier Change for MPO Hips, Substantially Equivalent on 2024-04-18. Applicant: Microport Orthopedics. Device class: 2.

Clearance details

Applicant: Microport Orthopedics
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2024-01-08
Decision date: 2024-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

view all

K253630 — Mpact 3D Metal Foam2026-08-28
K254043 — TRIVANCE Hip Stem2026-08-04
K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
K251270 — Taperloc® Complete Hip Stem2026-05-19

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.