APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD— 510(k) K101451

Name: FDA 510(k) clearance K101451
Creator: U.S. Food and Drug Administration
Published: 2010-06-22

Substantially Equivalent

Omni Life Science, Inc.

FDA 510(k) clearance K101451 for APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD, Substantially Equivalent on 2010-06-22. Applicant: Omni Life Science, Inc.. Device class: 2.

Clearance details

Applicant: Omni Life Science, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2010-05-25
Decision date: 2010-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: East Taunton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

view all

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 Omni Life Science, Inc.

view all

K191765 — OMNI TiN Coated Apex Knee System2019-09-25
K152919 — OMNI Skirted Heads2016-03-10
K131472 — APEX KNEE MODULAR TIBIA SYSTEM2013-10-08
K112891 — APEX REVISION KNEE SYSTEMS2012-02-29
K113242 — APEX ARC HIP STEM2012-01-05

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.