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510(k) Data Aggregation
Device Name
Affixus Retrograde Femoral Nailing SystemManufacturer
Date Cleared
2026-03-12
(115 days)
Product Code
Regulation Number
888.3020Type
TraditionalPanel
OrthopedicAge Range
All
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Affixus Retrograde Femoral Nailing System is indicated for:
- Compound and simple shaft fractures
- Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures
- Severely comminuted supracondylar fractures with articular involvement
- Fractures involving femoral condyles
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non union, and mal union
- Periprosthetic fractures
- Poly trauma patients
Device Description
The Affixus Retrograde Femoral Nailing System is part of the Affixus long bone nailing platform, designed for the treatment of a wide range of femoral fractures, from simple to complex. The system provides multiple locking options to support fracture stabilization and healing. All nails are made of type II anodized Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.
AI/ML Overview
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