BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS— 510(k) K090299

Name: FDA 510(k) clearance K090299
Creator: U.S. Food and Drug Administration
Published: 2009-04-24

Substantially Equivalent

Aesculap Implant Systems

FDA 510(k) clearance K090299 for BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS, Substantially Equivalent on 2009-04-24. Applicant: Aesculap Implant Systems. Device class: 2.

Clearance details

Applicant: Aesculap Implant Systems
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2009-02-06
Decision date: 2009-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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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.