Cleared Traditional

K023802 - SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TI...

K023802 is the FDA 510(k) clearance for SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TI... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K023802 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2003
Decision
75d
Days
Class 2
Risk

K023802 is an FDA 510(k) clearance for the SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on January 28, 2003 after a review of 75 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 Synthes (Usa) devices

Submission Details

510(k) Number K023802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2002
Decision Date January 28, 2003
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K023802.
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858 · Synthes (Usa) · Apr 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597 · Synthes (Usa) · Mar 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879 · Synthes (Usa) · Feb 2003
BIOMET CALCANEAL PLATE
K022515 · Biomet Orthopedics, Inc. · Sep 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · Synthes (Usa) · Jul 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · Synthes (Usa) · Jul 2002