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510(k) Data Aggregation
K Number
K221621Device Name
Pro-X1 Trochanteric Nailing System
Manufacturer
Date Cleared
2023-03-06
(276 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
X-Bolt Orthopedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in:
- · Intertrochanteric and subtrochanteric fractures
- · Segmental fractures
- Comminuted fractures
- Pathological fractures
- · Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union, and delayed union
- · Surgically created defects such as osteotomies
Device Description
The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components:
- . Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths.
- Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.
- Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement.
- Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.
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