Cleared Traditional

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (K152084) - FDA 510(k) Clearance

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

K152084 · Corentec Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
277d
Days
Class 2
Risk

K152084 is an FDA 510(k) clearance for the Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centraliz.... 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 April 29, 2016 after a review of 277 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. 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 K152084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date April 29, 2016
Days to Decision 277 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
155d slower than avg
Panel avg: 122d · This submission: 277d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K152084.
Smith & Nephew, Inc. REDAPT Augments
K171073 · Smith & Nephew, Inc. · Nov 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · Smith & Nephew, Inc. · Oct 2017
G7 Dual Mobility System, Active Articulation System
K161190 · Biomet, Inc. · May 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