Cleared Traditional

K013424 - INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND

K013424 is an FDA 510(k) clearance for INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND, manufactured by Hand Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K013424 · Hand Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
66d
Days
Class 2
Risk

K013424 is an FDA 510(k) clearance for the INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND. 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 December 20, 2001 after a review of 66 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K013424

510(k) Number K013424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 20, 2001
Days to Decision 66 days
Submission Type Traditional
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
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 203
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K013424.
FIXATION (STEINMANN) PINS
K013888 · Miltex, Inc. · May 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305 · Arthrotek, Inc. · Mar 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · Mitek Products · Feb 2002
OPUS MAGNUM ANCHOR & INSERTER
K012125 · Opus Medical, Inc. · Sep 2001
FLEX-NAILS
K012161 · Fixano SA · Aug 2001
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
K013424 · INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
Download PDF FDA Summary Hand Innovations, Inc.