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510(k) Data Aggregation
K Number
K181640Device Name
X-BOLT Hip Fracture Fixation System
Manufacturer
Date Cleared
2018-10-12
(113 days)
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
X-Bolt Orthopaedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip 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
The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in:
- · Intracapsular and extracapsular fractures of the femoral neck
- · Trochanteric fractures of the proximal femur
- · Stable subtrochanteric fractures of the proximal femur
Device Description
The X-BOLT® Hip Fracture Fixation System is a single use device intended for long-term (greater than 30 days) implantation into the femur or proximal femur. The system consists of two parts: the IM Hip Nailing System and the Dynamic Hip Plating System.
IM Hip Nailing System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® IM Hip Nail: A metal nail used with the X-BOLT® for femur fracture fixation.
C. End-Cap: Prevents bone ingrowth into the proximal end of the nail.
D. Set Screw: Prevents X-BOLT® rotation while allowing dynamic movement.
E. X-BOLT® Distal Locking Screws: Bone fixation screws used with the IM Hip Nail for distal fixation.
Dynamic Hip Plating System components:
A. X-BOLT®: An expanding hip bolt.
B. X-BOLT® Dynamic Hip Plate: An angled metal plate used with the X-BOLT® for proximal femur fracture fixation.
C. X-BOLT® Cortical Screws: Bone fixation screws used with the Dynamic Hip Plate for proximal femur fracture fixation.
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