Cleared Traditional

K112019 - BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP

K112019 is an FDA 510(k) clearance for BENCOX ID STEM, manufactured by Corentec Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K112019 · Corentec Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K112019

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
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
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K112019.
RENOVIS BIPOLAR HIP SYSTEM
K131354 · Renovis Surgical Technologies, LLC · Sep 2013
DEPUY CORAIL AMT HIP PROSTHESIS
K123991 · Depuy France S.A.S. · Sep 2013
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
K121509 · Tgm Medical, Inc. · Nov 2012
BIOPRO POLAR HEAD
K100761 · Biopro, Inc. · Dec 2010
UNITED U2 BIPOLAR IMPLANT
K101670 · United Orthopedic Corp. · Oct 2010
MEDACTA BIPOLAR HEAD
K091967 · Medacta International S.A. · Mar 2010