Cleared Traditional

K023365 - LEFORTE SYSTEM BONE SCREW

K023365 is an FDA 510(k) clearance for LEFORTE SYSTEM BONE SCREW, manufactured by Jeil Medical Corporation. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K023365 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
193d
Days
Class 2
Risk

K023365 is an FDA 510(k) clearance for the LEFORTE SYSTEM BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Deer Field, US). The FDA issued a Cleared decision on April 18, 2003 after a review of 193 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Jeil Medical Corporation devices

FDA 510(k) Submission Details - K023365

510(k) Number K023365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date April 18, 2003
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K023365.
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · Inion , Ltd. · Jun 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · Karl Storz Endoscopy · Jun 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · Inion , Ltd. · May 2003
STRYKER BIOZIP SUTURE ANCHOR
K023192 · Stryker Endoscopy · Mar 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · KARL STORZ Endoscopy-America, Inc. · Mar 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · Ebi, L.P. · Mar 2003