Cleared Special

K060864 - MULTIDIRECTIONAL THREADED PEG (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060864 · Hand Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
29d
Days
Class 2
Risk

K060864 is an FDA 510(k) clearance for the MULTIDIRECTIONAL THREADED PEG. 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 April 28, 2006 after a review of 29 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

Submission Details

510(k) Number K060864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2006
Decision Date April 28, 2006
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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.