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510(k) Data Aggregation
K Number
K233910Device Name
Vertex Hip Fracture Nailing System
Manufacturer
Date Cleared
2024-04-04
(114 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
OrthoXel DAC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vertex Hip Fracture Nailing System is intended for temporary fixation of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:
- Pertrochanteric fractures;
- · Intertrochanteric fractures;
- · High subtrochanteric fractures
- · Combinations of the above fractures, including non-union, malunion and tumor resections.
The Long Nail system is additionally indicated for use in adult patients for treatment of:
- · Pertrochanteric fractures associated with shaft fractures;
- · Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
- · Impending pathological fractures;
- · Long subtrochanteric fractures;
- · Ipsilateral femoral fractures;
- · Proximal or distal non-unions, malunions, revision procedures and tumor resections.
Device Description
The Vertex Hip Fracture Nailing (HFN) System is a cephalomedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided surgical instrumentation kit. Like many of the currently marketed intramedullary nails, the Vertex HFN offers several different proximal and distal locking options from which the surgeon may choose, depending on the nature of the fracture. The Vertex HFN System includes long and short cephalomedullary nails, lag screws, bone screws, and endcaps all of varying lengths and diameters. All parts of the system are manufactured from Titanium 6AL4VELi.
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