ACTIVELOCK MODULAR FEMORAL HIP SYSTEM— 510(k) K980020

Name: FDA 510(k) clearance K980020
Creator: U.S. Food and Drug Administration
Published: 1998-04-03

Substantially Equivalent for Some Indications

Metagen, LLC

FDA 510(k) clearance K980020 for ACTIVELOCK MODULAR FEMORAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1998-04-03. Applicant: Metagen, LLC. Device class: 2.

Clearance details

Applicant: Metagen, LLC
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 1998-01-05
Decision date: 1998-04-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K251270 — Taperloc® Complete Hip Stem2026-05-19

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K964003 — METAGEN ALL POLY ACETABULAR CUP SYSTEM1997-03-21
K963700 — METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM1997-02-12

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.