Cleared Traditional

K033286 - ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM

K033286 is an FDA 510(k) clearance for ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM, manufactured by Orthopedic Designs, Inc. (Odi). The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K033286 · Orthopedic Designs, Inc. (Odi) · Orthopedic device
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Jan 2004
Decision
90d
Days
Class 2
Risk

K033286 is an FDA 510(k) clearance for the ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthopedic Designs, Inc. (Odi) (St. Petersburg, US). The FDA issued a Cleared decision on January 12, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Orthopedic Designs, Inc. (Odi) devices

FDA 510(k) Submission Details - K033286

510(k) Number K033286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date January 12, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 432
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K033286.
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · Smith & Nephew, Inc. · Mar 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · Synthes (Usa) · Feb 2004
GAMMA3 NAIL SYSTEM
K034002 · Howmedica Osteonics Corp. · Jan 2004
MODIFICATION TO TELEGRAPH HUMERAL NAIL
K033510 · Fournitures Hospitalieres Industrie · Dec 2003
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · Depuy, Inc. · Nov 2003
T2 NAILING SYSTEM
K032523 · Howmedica Osteonics Corp. · Oct 2003