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GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities: - o GENTAFIX® 1 is a high viscosity bone cement intended for digital use. - . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application. - GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.

The F20 is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liguid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertecem is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid privation in this type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for: Dental or maxillo-facial surgery: - Filling after surgical curettage (cysts or benign tumors) - Osseous defects caused by a traumatic bone lesion. - Treatment of alveolar wall and crest defects

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The Opacity + Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Opacity + is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

ODONCER Bone Grafting Material is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectorny, and cystectomy. - Filling of extraction sockets to enhance preservation of the alveolar ridge. - Elevation of the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration and Guided Bone Regeneration. - Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration.

ODONCER is an osseo-conductive powder implant made of synthetic beta tricalcium phosphate (β-ΤCP (Cα3(PO4)2) indicated for bone grafting in dental applications.

Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painfull vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Spine-Fix is a self hardening and ready to use cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder

Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gaps, Cementek® LV resorbs and is replaced with bone during the healing process.

As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced with a syringe into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in an apatitic calcium phosphate cement. Cementek® LV is marketed in a 16cc dosage.

Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.

As a malleable bone substitute, Cementek® is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced as a paste into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in a apatitic calcium phosphate cement. Cementek is marketed in two different dosages; Cementek® 20 produces 8cc of paste and Cementek® 40 produces 16cc.

Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontancously. Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium phosphate(30% - 40%) and hydroxyapatite (60% - 70%). It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60% - 85% and the size of pores is 150 - 400μπ. Ceraform implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone. Ceraform is available in 5 gram, 10 gram and 15 grams dosages of granules that are approximately 3mm X 3mm in size, and sticks of packages of 5 and 10 units that are 5mm X 5mm X 20mm in size.