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PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.

PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.

Vivorté Trabexus™ EB" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté Trabexus™ EB™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté Trabexus™ EB" may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus " EB" is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté Trabexus™ EB™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). The device is provided in kit sizes of 3 cc. 5 cc. and 10 cc. corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite) which closely resembles the mineral phase of bone provides an osteoconductive scaffold and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together. Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.

OsteoSelect® DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony strtucture. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows: - Extremities . - Posterolateral spine - Pelvis

OsteoSelect® DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves. OsteoSelect® DBM Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.

MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied injection molded plastic spatula, funnel, and plunger. This product enables clinicians to generate a construct having a particular physical form and handling property. No additional carrier is added to the allograft material. This MAGNIFUSE® II Bone Graft product was prepared from human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. As a biological material, some variations in the product should be expected in both handling and appearance. The final product in packaged form was tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard <71>.

The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.

Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.

Accell Evo3c™ is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

The Accell Evo3c™ is an extension to the Accell Family of products cleared under 510(k) K061880. The Accell Family of products, including Accell Evo3c™, contain human demineralized bone matrix (DBM) in particulate and dispersed forms. The Accell Evo3c™ is the same as Accell A2i, submitted under 510(k) K061880, with the exception of the inclusion of cancellous bone chips which are added as an osteoconductive scaffold. The Accell A2i is marketed under the brand name "Accell Evo3™," hence the "c" in Accell Evo3c™ denotes the inclusion of cancellous chips in the formulation.

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the: | Putty | Mix | Paste | |----------------------|-------------|-------------| | Extremities | Extremities | Extremities | | Pelvis | Pelvis | Pelvis | | Posterolateral Spine | Spine | | | Cranium | | | DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is for single patient use only.

DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of donor cortical bone; the DBX® Mix is composed of donor corticocancellous bone. The bone granules are mixed with sodium hyaluronate (Hy) in varying combinations to form the DBX® Putty, Paste, and Mix.

Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

The Accell TBM-R is an extension to the Accell Family of Products 510(K) K061880. The Accell Family of Products, including Accell TBM-R, contain human demineralized bone matrix (ground, demineralized cortical bone). The Accell TBM-R is an addition to the Accell product family which has improved ease of use in handling characteristics and manual manipulation of the device.