Cleared Traditional

K033968 - HANSSON PIN SYSTEM

K033968 is an FDA 510(k) clearance for HANSSON PIN SYSTEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K033968 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
60d
Days
Class 2
Risk

K033968 is an FDA 510(k) clearance for the HANSSON PIN SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 60 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 - K033968

510(k) Number K033968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date February 20, 2004
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 205
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K033968.
MODIFICATION TO SMARTPIN
K041288 · Linvatec Biomaterials, Inc. · Jun 2004
ARTHROTEK LACTONAIL
K040500 · Arthrotek, Inc. · May 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · Bonutti Research, Inc. · Feb 2004
BIODHOC
K024185 · Future Medical Systems, SA · Jan 2004
SMALL BONE FIXATION SYSTEM
K033406 · Hand Innovations, Inc. · Jan 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
K033968 · HANSSON PIN SYSTEM
Download PDF FDA Summary Howmedica Osteonics C…