Cleared Traditional

K151307 - ICONACY(TM) I-Hip (TM)

K151307 is an FDA 510(k) clearance for ICONACY(TM) I-Hip (TM), manufactured by Iconacy Orthopedic Implants, LLC. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K151307 · Iconacy Orthopedic Implants, LLC · Orthopedic device
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Feb 2016
Decision
284d
Days
Class 2
Risk

K151307 is an FDA 510(k) clearance for the ICONACY(TM) I-Hip (TM). Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Iconacy Orthopedic Implants, LLC (Warsaw, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 284 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K151307

510(k) Number K151307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date February 26, 2016
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 477
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K151307.
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