Cleared Traditional

BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP (K112019) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112019 · Corentec Co., Ltd. · Orthopedic device
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Oct 2011
Decision
90d
Days
Class 2
Risk

K112019 is an FDA 510(k) clearance for the BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Corentec Co., Ltd. (Seocho Gu, Seoul, KR). The FDA issued a Cleared decision on October 12, 2011 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 888.3390 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Corentec Co., Ltd. devices

Submission Details

510(k) Number K112019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2011
Decision Date October 12, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 48
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K112019.
SurgTech Bipolar Head System
K173455 · Surgtech, Inc. · Jun 2018
ELEOS™ Bipolar Acetabular System
K180130 · Onkos Surgical, Inc. · Feb 2018
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · Signature Orthopaedics Pty, Ltd. · Jan 2018
MEDACTA BIPOLAR HEAD
K091967 · Medacta International S.A. · Mar 2010
GLADIATOR BIPOLAR SYSTEM
K062693 · Wrightmedicaltechnologyinc · Sep 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · Aesculap, Inc. · May 2006