Cleared Special

K050932 - DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM

K050932 is an FDA 510(k) clearance for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM, manufactured by Hand Innovations, Inc.. The device is a Class 2 Orthopedic device with product code LXT cleared through the Special 510(k) pathway after a 12-day FDA review.

K050932 · Hand Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
12d
Days
Class 2
Risk

K050932 is an FDA 510(k) clearance for the DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Hand Innovations, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on April 26, 2005 after a review of 12 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 - K050932

510(k) Number K050932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date April 26, 2005
Days to Decision 12 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
110d faster than avg
Panel avg: 122d · This submission: 12d
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 K050932.
WRIST FUSION PLATE
K052754 · Dvo Extremity Solutions, LLC · Oct 2005
MODIFICATION TO SHOULDER FIXATION SYSTEM
K051728 · Hand Innovations, LLC · Jul 2005
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K051306 · Howmedica Osteonics Corp. · Jun 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631 · Synthes (Usa) · Apr 2005
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458 · A.M. Surgical, Inc. · Oct 2004
SHOULDER FIXATION SYSTEM
K042059 · Hand Innovations, Inc. · Sep 2004
K050932 · DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
Download PDF FDA Summary Hand Innovations, Inc.