Cleared Special

K131279 - ICONACY I-HIP SYSTEM

K131279 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 Special 510(k) pathway after a 95-day FDA review.

K131279 · Iconacy Orthopedic Implants, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
95d
Days
Class 2
Risk

K131279 is an FDA 510(k) clearance for the ICONACY I-HIP 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 August 9, 2013 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131279

510(k) Number K131279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date August 09, 2013
Days to Decision 95 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

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 560
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K131279.
OVATION 10/12 HIP STEM
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PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K132626 · Pipeline Biotechnology · Sep 2013
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K130353 · Pipeline Orthopedics · Jul 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · Encore Medical, L.P. · Jun 2013
PIPELINE TOTAL HIP SYSTEM
K131237 · Pipeline Orthopedics · Jun 2013