Cleared Traditional

ODI TALON INTRAMEDULLARY HIP NAIL (K014189) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014189 · Orthopedic Designs, Inc. · Orthopedic device
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Mar 2002
Decision
90d
Days
Class 2
Risk

K014189 is an FDA 510(k) clearance for the ODI TALON INTRAMEDULLARY HIP NAIL. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Orthopedic Designs, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on March 21, 2002 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 888.3030 - 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. devices

Submission Details

510(k) Number K014189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date March 21, 2002
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 35
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K014189.
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · Synthes (Usa) · Apr 2004
TRIGEN INTERTAN
K040212 · Smith & Nephew, Inc. · Feb 2004
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · Synthes (Usa) · Nov 2003
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · Synthes (Usa) · Oct 2000
PEDIATRIC FIXATION RODS
K000764 · Biomet, Inc. · Apr 2000
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · Howmedica Osteonics Corp. · Oct 1999