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Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous bone void filler for the repair of bony defects made from a combination of beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin and sodium carboxymethyl cellulose. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a specified volume of hydration fluid is combined with the dry component of the device. Mixing is facilitated by a syringe to syringe mixing system. The resulting material can be administered to the treatment site by injection through a cannula or by manual application. After injection or insertion into the defect site new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site. HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. HydroSet XT cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support medium and is not intended to provide structural support during the healing process.

HydroSet XT is a self-setting calcium phosphate cement. The device includes a pre-filled liquid syringe and a pre-filled powder syringe utilized for mixing and delivery of the cement. The device also includes the necessary components to prepare and deliver the cement (syringe cap, luer adapter, luer cap, threaded plunger, and cannula). After preparation, the cement may be delivered by traditional plunger advancement or by rotating the threaded plunger to deliver the cement.

Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during process.

Vitoss BiModal Foam Strip is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 to 1000 um. Vitoss BiModal Foam Strip guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BiModal Foam Strip is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler. The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

The Stryker KWIC (K-wire Insertion Cannulated) Needle is a manually operated needle that is used to assist in the placement of guidewires (e.g. K-wires) and/or the aspiration of autologous blood or bone marrow for orthopedic surgery. The Stryker KWIC Needle is designed to interface with already-cleared Stryker navigation systems. This device is to be manually calibrated and used with Stryker navigation systems. This device is intended to be used in spine applications to perform general manual functions within the orthopedic environment including the placement of guidewires (e.g. K-wires) or to draw bone marrow. Guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

Vitoss BA Bimodal Bioactive Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Bimodal is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BA Bimodal Bioactive Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss BA Bimodal Bioactive Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um. Vitoss BA Bimodal Bioactive Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BA Bimodal Bioactive Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an aid in spinal fixation. Machined from medical grade PEEK-OPTIMA®, the device is trapezoidal in shape with a hollow frame to accept autogenous bone graft. ORTHOVITA PEEK SPACER is available in a range of heights and geometries to accommodate individual pathologies and anatomical conditions.

FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um. FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

VITOMATRIX is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectomy, 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 (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

VITOMATRIX is a resorbable bone grafting material composed of β-Tricalcium Phosphate intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile and available in .2 1mm and 1-2mm morsel sizes. VITOMATRIX guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When VITOMATRIX is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.