Succession™ AFN System

FDA 510(k) K250622 · Ortho Solutions UK , Ltd.

Substantially Equivalent

510(k) numberK250622

Submission

Device name
Succession™ AFN System
Applicant
Ortho Solutions UK , Ltd.
Maldon, GB
Received
February 28, 2025
Decision date
August 7, 2025
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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K261481Pangea Femur Reconstruction SystemHSB · Traditional Stryker GmbH06/29/2026SE
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K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional Suzhou and Science & Technology Development Corp.06/18/2026SE
K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional Beijing Fule Science & Technology Development…06/17/2026SE
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

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Questions and answers

When was Succession™ AFN System cleared by the FDA?

Succession™ AFN System (K250622) received a 510(k) decision of Substantially Equivalent on August 7, 2025, 160 days after the submission was received.

What is the product code of K250622?

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