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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.

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.

For orthopedic use, the OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone

OrthoBlast® II DBM Putty and Paste is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency. OrthoBlast® II DBM Putty and Paste are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

OrthoBlast® II is an osteoinductive and osteoconductive bone filling material indicated: OrthoBlast® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OrthoBlast" II is included to be packed gently mo bony gapo in the exercial see defects may be surgically created or from the result of traumatic injury to the bone.

OrthoBlast® II is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous bone from the same donor, and formulated to a gel or putty-like consistency.

For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

IsoTis OrthoBiologics is expanding the range of sizes previously cleared in 510(k) K050690 to include Connexus, 0.5cc. The intended use of this additional size does not change from that previously cleared. Connexus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

DynaGraft II Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes: - Filling of defects after root resection, apicoectomy and cystectomy - - Filling of extraction sockets to enhance preservation of the alveolar ridge - - Elevation of maxillary sinus floor - - Treatment of periodontal defects -

DynaGraft® II Dental is derived from selected donated human borne tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a gel or putty-like consistency.

For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

Connexus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

DynaGraft® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. DynaGraft® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

DynaGraft II is derived from selected donated human bone tissue that has been processed into particles. The demineralized bone matrix (DBM) is combined with a hydrogel carrier and formulated to a gel or putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of maxillary sinus floor and treatment of periodontal defects.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 200μm -2000um.

Aspirex" - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone marrow with bone void filler and deliver to the orthopedic surgical site.

The Aspirex™ - Bone Marrow Aspirate Kit contains two piston syringes: Aspirating Syringe and Infusion Chamber Syringe. These piston syringes along with a single lumen Aspirating Needle, Stylet, Luer-lock Adaptor, Cleaning Rod, Mixing Bowl and Spatula make up the components of the Aspirex™ Kit (will be packaged in various configurations, sizes, and quantities of these components).