Cleared Special

K220468 - BENCOX Mirabo Cup System

K220468 is an FDA 510(k) clearance for BENCOX Mirabo Cup System, 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 90-day FDA review.

K220468 · Corentec Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
90d
Days
Class 2
Risk

K220468 is an FDA 510(k) clearance for the BENCOX Mirabo Cup System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Corentec Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on May 18, 2022 after a review of 90 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 - K220468

510(k) Number K220468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2022
Decision Date May 18, 2022
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K220468.
Smith & Nephew Hip Systems
K211176 · Smith & Nephew, Inc. · Jul 2022
DePuy 3D Additive TriFlange Acetabular Cup
K201348 · Depuy International, Ltd. · Jun 2022
BENCOX Mirabo Z Cup Cortinium
K210614 · Corentec Co., Ltd. · May 2022
Biocore9 Acetabular Cup System
K212761 · Biocore9, LLC · May 2022
Acetabular Dome Hole Plug
K220376 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2022
Restoration® Modular Hip System
K212187 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2022
K220468 · BENCOX Mirabo Cup System
Download PDF FDA Summary Corentec Co., Ltd.