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TRAUMACEM™ V+ Augmentation System
The TRAUMACEM V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED Proximal Femoral Nailing System (TFNA) through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).
The TRAUMACEM V+ is a polymethylmethacrylate (PMMA) cement with specific indications for augmentation of a trauma device, allowing surgeons to inject a controlled amount of cement into the femoral head in patients with poor bone quality, reducing the risk of cut-out.
The TRAUMACEM V+ Augmentation System is offered for use with the TFNA System and builds on the list of comprehensive surgical options that the TFNA System offers.
Features & Benefits
Comprehensive Surgical Solutions
The TFNA System provides an extensive range of proximal femoral nailing options, including:
Blade/screw head element
Locking options
Nail lengths & diameters
*Optional Augmentation
Head element design enables intraoperative decision making
Fenestrated head elements perform equivalent to solid head elements, thus enabling choice of augmentation with a single implant design*.
*DePuy Synthes test data on file, Windchill 0000267150
Controlled Injection
Inject a controlled amount of cement into the femoral head using an injection cannula and fenestrated head element, providing strong implant fixation.
Specifically Selected
Initial viscosity of TRAUMACEM V+ Injectable Bone cement allows for cement injection immediately after mixing with no wait time. Cement working time begins immediately and lasts for up to 27 minutes at room temperature. Radiopaque design enables visualization under fluoroscopy to detect cement flow.
Outcomes-Based Design
This system is designed to improve patient outcomes by addressing some of the most pressing clinical challenges, such as poor bone quality.
Reduced Procedural Complexity
The TFNA System is designed to improve efficiency and ease of use for surgeons and OR staff with lateral visualization, back table instrument simplicity, and intraoperative flexibility.
Supporting Documentation
Resources
Value Analysis Brief - Full Version
Value Analysis Brief - Augmentation Only
Quick Step Guide
Hip & Femur Fracture Brochure
References
No references available for this product.
Indication Statement
TFNA System with Augmentation
Indications:
• Both the short and long TFNA Systems are additionally indicated for use with cleared, polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality
Contraindications:
• Risk for intra-articular cement leakage
• Acute traumatic fractures with good bone quality
• Intracapsular hip fractures
• In the presence of active or incompletely treated infection at the site where the bone cement is to be applied
TRAUMACEM™ V+ Injectable Bone Cement
Indications:
• The TRAUMACEM V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).
Contraindications:
• Risk for cement leakage outside the intended application site
• Intracapsular hip fractures
• PMMA bone cement is contraindicated in the presence of active or incompletely treated infection at the site where the bone cement is to be applied
• Patients with severe cardiac and/or pulmonary insufficiency
• Patients with known hypersensitivity or allergy to any of the components of cement
• Application to children or to women during pregnancy or lactation
• Arthroplasty procedures
• Acute traumatic fractures with good bone quality
094448-180703
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