Cleared Special

K033406 - SMALL BONE FIXATION SYSTEM

K033406 is an FDA 510(k) clearance for SMALL BONE FIXATION SYSTEM, manufactured by Hand Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 83-day FDA review.

K033406 · Hand Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
83d
Days
Class 2
Risk

K033406 is an FDA 510(k) clearance for the SMALL BONE FIXATION SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Hand Innovations, Inc. (Miami, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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, Inc. devices

FDA 510(k) Submission Details - K033406

510(k) Number K033406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2003
Decision Date January 15, 2004
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 139
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K033406.
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
ARTHROTEK LACTONAIL
K040500 · Arthrotek, Inc. · May 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
INION OTPS BIODEGRADABLE PIN
K031712 · Inion , Ltd. · Aug 2003
K-FIX
K022597 · New Deal, S.A. · Nov 2002