Cleared Traditional

K023360 - LEFORTE SYSTEM BONE PLATE

K023360 is an FDA 510(k) clearance for LEFORTE SYSTEM BONE PLATE, manufactured by Jeil Medical Corporation. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K023360 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
18d
Days
Class 2
Risk

K023360 is an FDA 510(k) clearance for the LEFORTE SYSTEM BONE PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Deer Field, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jeil Medical Corporation devices

FDA 510(k) Submission Details - K023360

510(k) Number K023360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date October 25, 2002
Days to Decision 18 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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 27
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K023360.
AOS PROXIMAL HUMERAL PLATE
K080590 · Advanced Orthopaedic Solutions, Inc. · May 2008
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · Synthes (Usa) · Mar 2008
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920 · Orthofix Srl · Nov 2006
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · Alliance Medical Corp. · Jun 2002
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · Synthes (Usa) · Sep 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · Synthes (Usa) · Aug 2001