Cleared Traditional

K031428 - SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE

K031428 is an FDA 510(k) clearance for SYNTHES (USA) LARGE EXTERNAL FIXATION C..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K031428

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.

LXT Device Classification - Class 2, Special Controls

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 46
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