Cleared Traditional

K133228 - ICONACY I-HIP SYSTEM

K133228 is an FDA 510(k) clearance for ICONACY I-HIP SYSTEM, 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 88-day FDA review.

K133228 · Iconacy Orthopedic Implants, LLC · Orthopedic device
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Jan 2014
Decision
88d
Days
Class 2
Risk

K133228 is an FDA 510(k) clearance for the ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM. 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 January 17, 2014 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iconacy Orthopedic Implants, LLC devices

FDA 510(k) Submission Details - K133228

510(k) Number K133228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date January 17, 2014
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K133228.
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OVATION 10/12 HIP STEM
K131022 · Ortho Development Corp. · Oct 2013
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K132207 · United Orthopedic Corporation · Aug 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · Encore Medical, L.P. · Jun 2013