Cleared Special

K182221 - Bencox Mirabo Cup Multi Hole

K182221 is an FDA 510(k) clearance for Bencox Mirabo Cup Multi Hole, manufactured by Corentec Co., Ltd.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 228-day FDA review.

K182221 · Corentec Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
228d
Days
Class 2
Risk

K182221 is an FDA 510(k) clearance for the Bencox Mirabo Cup Multi Hole. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Corentec Co., Ltd. (Cheonan, KR). The FDA issued a Cleared decision on April 1, 2019 after a review of 228 days - an extended review 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. 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 - K182221

510(k) Number K182221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2018
Decision Date April 01, 2019
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K182221.
MicroPort CoCr Femoral Heads
K190123 · Microport Orthopedics, Inc. · Jul 2019
DJO Acetabular System
K190057 · Encore Medical, L.P. · Jun 2019
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
K182678 · Zimmer, Inc. · May 2019
MPACT Extension
K183582 · Medacta International S.A. · Mar 2019
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
K182468 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Mar 2019
Alteon Acetabular Cup System
K182502 · Exactech, Inc. · Mar 2019
K182221 · Bencox Mirabo Cup Multi Hole
Download PDF FDA Summary Corentec Co., Ltd.