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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 197
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K033717.
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
MODIFICATION TO SMARTPIN
K041288 · Linvatec Biomaterials, Inc. · Jun 2004
ARTHROTEK LACTONAIL
K040500 · Arthrotek, Inc. · May 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
BIODHOC
K024185 · Future Medical Systems, SA · Jan 2004
SMALL BONE FIXATION SYSTEM
K033406 · Hand Innovations, Inc. · Jan 2004
K033717 · TRANSET FRACTURE FIXATION SYSTEM
Download PDF FDA Summary Bonutti Research, Inc.