Cleared Traditional

K031428 - SYNTHES (USA) LARGE EXTERNAL FIXATION C...

K031428 is the FDA 510(k) clearance for SYNTHES (USA) LARGE EXTERNAL FIXATION C... by Synthes (Usa). It is a Class 2 Orthopedic device (product code LXT) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K031428 · Synthes (Usa) · Orthopedic device
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Aug 2003
Decision
94d
Days
Class 2
Risk

K031428 is an FDA 510(k) clearance for the SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 8, 2003 after a review of 94 days - within the typical 510(k) review window.

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: 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 Synthes (Usa) devices

Submission Details

510(k) Number K031428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2003
Decision Date August 08, 2003
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 33
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K031428.
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
K033805 · Synthes (Usa) · Feb 2004
HOFFMANN II PELVIC CLAMP
K033145 · Howmedica Osteonics Corp. · Nov 2003
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
K031973 · Synthes (Usa) · Sep 2003
STRYKER PLATING SYSTEM PERIARTICULAR PLATES
K031959 · Howmedica Osteonics Corp. · Jul 2003
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K030390 · Synthes (Usa) · Apr 2003
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651 · Howmedica Osteonics Corp. · Oct 2002