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510(k) Data Aggregation
K Number
K203381Device Name
Dynanail Mini Hybrid
Manufacturer
MedShape Inc
Date Cleared
2021-01-15
(59 days)
Product Code
HWC, JDS
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MedShape Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
Device Description
The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
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