IOI TOTAL HIP— 510(k) K121034

Name: FDA 510(k) clearance K121034
Creator: U.S. Food and Drug Administration
Published: 2012-09-04

Substantially Equivalent

Iconacy Orthopedic Implants, LLC

FDA 510(k) clearance K121034 for IOI TOTAL HIP, Substantially Equivalent on 2012-09-04. Applicant: Iconacy Orthopedic Implants, LLC. Device class: 2.

Clearance details

Applicant: Iconacy Orthopedic Implants, LLC
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2012-04-05
Decision date: 2012-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Iconacy Orthopedic Implants, LLC

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K160266 — ICONACY(TM) I-Hip(TM)2016-04-08
K151307 — ICONACY(TM) I-Hip (TM)2016-02-26
K132572 — I-HIP TOTAL HIP SYSTEM2014-03-28
K133228 — ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM2014-01-17
K131279 — ICONACY I-HIP SYSTEM2013-08-09

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.