Biolox® Delta Revision heads— 510(k) K243809

Name: FDA 510(k) clearance K243809
Creator: U.S. Food and Drug Administration
Published: 2025-03-04

Substantially Equivalent

Limacorporate

FDA 510(k) clearance K243809 for Biolox® Delta Revision heads, Substantially Equivalent on 2025-03-04. Applicant: Limacorporate. Device class: 2.

Clearance details

Applicant: Limacorporate
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2024-12-11
Decision date: 2025-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villanova Di San Daniele Del Friuli, IT

Download summary PDF View on FDA.gov ↗

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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

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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, 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.