Cleared Traditional

K033968 - HANSSON PIN SYSTEM

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

K033968 · Howmedica Osteonics Corp. · Orthopedic device
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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.

View all Howmedica Osteonics Corp. devices

Submission Details

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.

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 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K033968.
ARTHREX BIO-PIN
K050259 · Arthrex, Inc. · May 2005
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 2005
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001