Cleared Special

K160266 - ICONACY(TM) I-Hip(TM)

K160266 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 LPH cleared through the Special 510(k) pathway after a 66-day FDA review.

K160266 · Iconacy Orthopedic Implants, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
66d
Days
Class 2
Risk

K160266 is an FDA 510(k) clearance for the ICONACY(TM) I-Hip(TM). 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 April 8, 2016 after a review of 66 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. 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. Low regulatory complexity profile. 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 - K160266

510(k) Number K160266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2016
Decision Date April 08, 2016
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 Consultant

C L Vierling, LLC
Carol Vierling

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K160266.
Stryker Orthopaedics Hip Systems Labeling Update
K153345 · Stryker Orthopaedics · May 2016
Escalade Legend Acetabular Shell
K161080 · Ortho Development Corporation · May 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
K152084 · Corentec Co., Ltd. · Apr 2016
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · Smith & Nephew, Inc. · Nov 2015
Arcos One-piece Femoral Revision System
K151603 · Biomet, Inc. · Oct 2015
Exactech® Novation® Crown Cup®
K141960 · Exactech, Inc. · Sep 2015