Cleared Traditional

MODIFICATION TO SMALL BONE FIXATION SYSTEM (K041157) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041157 · Hand Innovations, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
88d
Days
Class 2
Risk

K041157 is an FDA 510(k) clearance for the MODIFICATION TO 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 July 30, 2004 after a review of 88 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.

View all Hand Innovations, Inc. devices

Submission Details

510(k) Number K041157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date July 30, 2004
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K041157.
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 2007
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · Arthrex, Inc. · Nov 2005
ARTHREX BIO-PIN
K050259 · Arthrex, Inc. · May 2005
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003