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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.

EUROSCREW® NG and EUROSCREW® NG TCP screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.

Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are bioabsorbable interference screws used in ligament surgery specifically designed for fixation of both bone-tendon-bone and soft tissue grafts. The screws are suitable and designed for ligamentoplasty surgical procedures specifically for knee anterior cruciate ligament reconstructions. Both are implantable screw devices in long term contact with bone and tissue grafts. Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are implant devices that are utilized in a surgical setting with a qualified healthcare professional (i.e., surgeons).

The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).

HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ 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 COHESION Bone Cement 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).

The purpose of this submission is to submit a new bone cement that is a modification of Vertecem and Opacity+ bone cements, previously cleared on K090435 and K080873, respectively. Cohesion has the same indications for use as the predicate devices. Another similarity is that 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 liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. Cohesion is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates Cohesion allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.

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