Cleared Traditional

K031178 - SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM...

K031178 is the FDA 510(k) clearance for SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K031178 · Synthes (Usa) · Orthopedic device
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May 2003
Decision
21d
Days
Class 2
Risk

K031178 is an FDA 510(k) clearance for the SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES. 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 May 5, 2003 after a review of 21 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 K031178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date May 05, 2003
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 K031178.
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032 · Synthes (Usa) · Sep 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · Synthes (Usa) · Aug 2003
TEXAS T - PLATE
K031334 · Biomet, Inc. · May 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310 · Synthes (Usa) · Apr 2003
AAP ACROPLATE
K030909 · Aap Implantate AG · Apr 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858 · Synthes (Usa) · Apr 2003