Talon DistalFix Antegrade/Retrograde Femoral Nail

FDA 510(k) K152295 · Orthopedic Designs North America, Inc.

Substantially Equivalent

510(k) numberK152295

Submission

Device name
Talon DistalFix Antegrade/Retrograde Femoral Nail
Applicant
Orthopedic Designs North America, Inc.
Tampa, FL, US
Received
August 13, 2015
Decision date
November 3, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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K253046HERA Interlocking Intramedullary Nailing SystemHSB · Traditional ZheJiang Decans Medical Devices Co., Ltd.06/16/2026SE
K260146Fitbone® Transport and Lengthening SystemHSB · Traditional Orthofix Srl05/19/2026SE
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional Orthofix Srl05/08/2026SE
K261043AUTOBAHN™ Nailing SystemHSB · Special Globus Medical, Inc.04/24/2026SE
K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
K252961Fusion FibFix NailHSB · Traditional Fusion Orthopedics USA, LLC03/18/2026SE

More from Fusion Orthopedics USA, LLC

510(k)DeviceDecision
K210146Cannulated Compression Device SystemHWC · Traditional 04/13/2022SE
K173255Talon DistalFix Humeral NailHSB · Traditional 02/22/2018SE
K111352Talon Distalfix Proximal Femoral NailHSB · Abbreviated 08/22/2011SE

Questions and answers

When was Talon DistalFix Antegrade/Retrograde Femoral Nail cleared by the FDA?

Talon DistalFix Antegrade/Retrograde Femoral Nail (K152295) received a 510(k) decision of Substantially Equivalent on November 3, 2015, 82 days after the submission was received.

What is the product code of K152295?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.