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)
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.

View all Iconacy Orthopedic Implants, LLC devices

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
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 477
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K131279.
MPACT EXTENSION
K132879 · Medacta International · Jan 2014
OVATION 10/12 HIP STEM
K131022 · Ortho Development Corp. · Oct 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
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
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · United Orthopedic Corporation · Jun 2013
UTF STEM, REDUCED
K123550 · United Orthopedic Corporation · May 2013