Cleared Traditional

K210614 - BENCOX Mirabo Z Cup Cortinium

K210614 is the FDA 510(k) clearance for BENCOX Mirabo Z Cup Cortinium by Corentec Co., Ltd.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K210614 · Corentec Co., Ltd. · Orthopedic device
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May 2022
Decision
449d
Days
Class 2
Risk

K210614 is an FDA 510(k) clearance for the BENCOX Mirabo Z Cup Cortinium. 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 24, 2022 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Corentec Co., Ltd. devices

Submission Details

510(k) Number K210614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date May 24, 2022
Days to Decision 449 days
Submission Type Traditional
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
327d slower than avg
Panel avg: 122d · This submission: 449d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 424
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