Cleared Traditional

K014189 - ODI TALON INTRAMEDULLARY HIP NAIL

K014189 is an FDA 510(k) clearance for ODI TALON INTRAMEDULLARY HIP NAIL, manufactured by Orthopedic Designs, Inc.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K014189 · Orthopedic Designs, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K014189

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
Combination Product No
PCCP Authorized No
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.

JDS Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K014189.
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · Synthes (Usa) · Nov 2003
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · Noviace Corporation · Oct 2003
BNF
K021782 · Aap Implantate AG · Aug 2002
BAUMER LOCKING NAIL
K011504 · Baumer, S.A · Aug 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · Disco-O-Tech Medical Technologies, Ltd. · Dec 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · Disco-O-Tech Medical Technologies, Ltd. · Dec 2000
K014189 · ODI TALON INTRAMEDULLARY HIP NAIL
Download PDF FDA Summary Orthopedic Designs, I…