Cleared Traditional

K041157 - MODIFICATION TO SMALL BONE FIXATION SYSTEM

K041157 is an FDA 510(k) clearance for MODIFICATION TO SMALL BONE FIXATION SYSTEM, 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 88-day FDA review.

K041157 · Hand Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K041157

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
Combination Product No
PCCP Authorized No
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.

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 K041157.
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339 · Xtremi-T, LLC · Apr 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
K050275 · Inion , Ltd. · Mar 2005
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 2005
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
MODIFICATION TO SMARTPIN
K041288 · Linvatec Biomaterials, Inc. · Jun 2004
ARTHROTEK LACTONAIL
K040500 · Arthrotek, Inc. · May 2004
K041157 · MODIFICATION TO SMALL BONE FIXATION SYSTEM
Download PDF FDA Summary Hand Innovations, Inc.