Cleared Traditional

K121034 - IOI TOTAL HIP

K121034 is an FDA 510(k) clearance for IOI TOTAL HIP, manufactured by Iconacy Orthopedic Implants, LLC. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K121034 · Iconacy Orthopedic Implants, LLC · Orthopedic device
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Sep 2012
Decision
152d
Days
Class 2
Risk

K121034 is an FDA 510(k) clearance for the IOI TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Iconacy Orthopedic Implants, LLC (Warsaw, US). The FDA issued a Cleared decision on September 4, 2012 after a review of 152 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Iconacy Orthopedic Implants, LLC devices

FDA 510(k) Submission Details - K121034

510(k) Number K121034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2012
Decision Date September 04, 2012
Days to Decision 152 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 122d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 477
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K121034.
NOVATION LPI PRIME FEMORAL STEM
K121684 · Exactech, Inc. · Oct 2012
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
K113296 · Zimmer, Inc. · Sep 2012
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
K120924 · Corentec Co., Ltd. · Sep 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · Smith & Nephew, Inc. · Aug 2012
TAPERLOC COMPLETE SIZE 4MM AND XR 123
K120030 · Biomet Manufacturing Corp · Aug 2012
HIP SYSTEMS
K121308 · Howmedica Osteonics Corp. · Jul 2012