Cleared Special

K051728 - MODIFICATION TO SHOULDER FIXATION SYSTEM

K051728 is an FDA 510(k) clearance for MODIFICATION TO SHOULDER FIXATION SYSTEM, manufactured by Hand Innovations, LLC. The device is a Class 2 Orthopedic device with product code LXT cleared through the Special 510(k) pathway after a 23-day FDA review.

K051728 · Hand Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
23d
Days
Class 2
Risk

K051728 is an FDA 510(k) clearance for the MODIFICATION TO SHOULDER FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Hand Innovations, LLC (Miami Lakes, US). The FDA issued a Cleared decision on July 20, 2005 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051728

510(k) Number K051728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date July 20, 2005
Days to Decision 23 days
Submission Type Special
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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 56
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K051728.
PTA (PROGRESSIVE TIBIAL ALIGNMENT)
K060403 · Meridian Medical · Mar 2006
SHOULDER FIXATION SYSTEM
K060290 · Hand Innovations, LLC · Feb 2006
WRIST FUSION PLATE
K052754 · Dvo Extremity Solutions, LLC · Oct 2005
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K051306 · Howmedica Osteonics Corp. · Jun 2005
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
K050932 · Hand Innovations, Inc. · Apr 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631 · Synthes (Usa) · Apr 2005
K051728 · MODIFICATION TO SHOULDER FIXATION SYSTEM
Download PDF FDA Summary Hand Innovations, LLC