TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM— 510(k) K020963

Name: FDA 510(k) clearance K020963
Creator: U.S. Food and Drug Administration
Published: 2002-04-16

Substantially Equivalent

Biomet Orthopedics, Inc.

FDA 510(k) clearance K020963 for TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM, Substantially Equivalent on 2002-04-16. Applicant: Biomet Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Biomet Orthopedics, Inc.
Product code: Product code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2002-03-25
Decision date: 2002-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEH

view all

K261576 — Icona Hip Stem2026-08-10
K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
K251166 — Mfinity Femoral System2025-06-13
K251052 — Trivicta® Hip Stem2025-05-22
K242315 — Resolve Modular Revision Hip Stem2025-05-01

More clearances from Biomet Orthopedics, Inc.

view all

K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
K080528 — E-POLY TIBIAL BEARINGS2008-06-17
K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM2008-01-14
K070955 — ACID ETCHED LAG SCREWS2007-10-12
K033355 — LACTOSCREW SCREW ANCHOR2004-06-30

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.