Cleared Special

K061748 - FRAGMENT PLATE SYSTEM

K061748 is an FDA 510(k) clearance for FRAGMENT PLATE SYSTEM, manufactured by Hand Innovations, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 26-day FDA review.

K061748 · Hand Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
26d
Days
Class 2
Risk

K061748 is an FDA 510(k) clearance for the FRAGMENT PLATE SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Hand Innovations, LLC (Warsaw, US). The FDA issued a Cleared decision on July 17, 2006 after a review of 26 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.

View all Hand Innovations, LLC devices

FDA 510(k) Submission Details - K061748

510(k) Number K061748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2006
Decision Date July 17, 2006
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 325
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K061748.
AEQUALIS HUMERAL PLATE
K063551 · Tornier · Dec 2006
REPROCESSED EXTERNAL FIXATION DEVICE
K061759 · Ascent Healthcare Solutions · Sep 2006
OMEGA 3 SYSTEM
K062066 · Howmedica Osteonics Corp. · Aug 2006
UNITY HUMERAL PLATE
K060545 · Tornier · Apr 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · Howmedica Osteonics Corp. · Apr 2006
REPROCESSED EXTERNAL FIXATION DEVICES
K052918 · Alliance Medical Corp. · Jan 2006