Cleared Traditional

K033717 - TRANSET FRACTURE FIXATION SYSTEM

K033717 is an FDA 510(k) clearance for TRANSET FRACTURE FIXATION SYSTEM, manufactured by Bonutti Research, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K033717 · Bonutti Research, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
91d
Days
Class 2
Risk

K033717 is an FDA 510(k) clearance for the TRANSET FRACTURE FIXATION SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on February 25, 2004 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bonutti Research, Inc. devices

FDA 510(k) Submission Details - K033717

510(k) Number K033717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date February 25, 2004
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 112
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K033717.
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K050275 · Inion , Ltd. · Mar 2005
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 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
INION OTPS BIODEGRADABLE PIN
K031712 · Inion , Ltd. · Aug 2003