Cleared Traditional

K103431 - COREN TOTAL HIP SYSTEM

K103431 is an FDA 510(k) clearance for COREN TOTAL HIP SYSTEM, manufactured by Corentec Co., Ltd.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K103431 · Corentec Co., Ltd. · Orthopedic device
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Jul 2011
Decision
240d
Days
Class 2
Risk

K103431 is an FDA 510(k) clearance for the COREN TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Corentec Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on July 21, 2011 after a review of 240 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

FDA 510(k) Submission Details - K103431

510(k) Number K103431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2010
Decision Date July 21, 2011
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K103431.
POLARCUP DUAL MOBILITY SYSTEM
K110135 · Smith & Nephew, Inc. · Oct 2011
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
K111472 · Tgm Medical · Sep 2011
UNITED UTF STEM
K110245 · United Orthopedic Corporation · Aug 2011
U2 HIP SYSTEM
K111546 · United Orthopedic Corp. · Jul 2011
APEX K1 HIP STEM
K110947 · Omni Life Science, Inc. · Jun 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662 · Zimmer, Inc. · Apr 2011