Orthopedic and spine allograft tissue processing

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Orthopedic and Spine

Bone Shaft

The allograft heart valve product is derived from a cadaveric donated heart 48h after cardiac arrest. Prior to retrieving the whole heart from a mortuary or dedicated donation suite, the donor screening in case of age limitation (1 to 55 years old), medical history, and physical examination is performed. Then, the valve is carefully dissected from the heart in a licensed pharmaceutical grade cleanroom (GMP classification B) to remove excess myocardium, fat, and connective tissue. At this stage, the valve is treated with an antibiotic cocktail to reduce the bioburden. It should also be noted that in order to assure the product safety, several quality control tests such as microbiologic & serologic assays are carried out; each sample is tested for aerobic and anaerobic bacteria, fungi & HIV antibodies type 1, 2 (anti- HIV1&2), antibody to human T-lymphotropic virus type 1,2 (HTLV Ab1,2), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCVAb), Hepatitis B surface Antigen (HBsAg), and RPR for syphilis.

Bone Wedge

Bone wedge allografts are typically composed of dense cancellous bone with either no cortical ridges or a single/multiple cortical ridges. The cancellous bone provides a natural scaffold for bone ingrowth, while the cortical ridges provide additional structural support. Allogenic wedge bone grafts are a specific type of allogenic bone graft shaped like a triangle. They are commonly used in orthopedic surgeries to restore bone defects and provide structural support. One of the main uses of allogenic wedge bone grafts is in bone defect reconstruction. These grafts are often employed when there is a significant bone defect resulting from trauma, tumor resection, or congenital abnormalities. By filling in the missing bone, allogenic wedge bone grafts help restore the bone’s integrity and provide support for proper healing. Another application of allogenic wedge bone grafts is in corrective osteotomies. Corrective osteotomy procedures involve cutting and realigning a bone to correct deformities or malalignment. The use of allogenic wedge bone grafts can help maintain the corrected position and facilitate bone healing in these cases.

DBM Putty

Demineralized bone matrix (DBM) putty is a highly specialized bone graft material that has emerged as a valuable tool in the surgical management of bone defects. Derived from human or animal bone that has been processed to remove its mineral components, DBM putty presents a soft, malleable scaffold richly endowed with osteoconductive and osteoinductive properties. These properties enable DBM putty to serve as a platform for bone cell attachment, proliferation, and differentiation, fostering the regeneration of new bone tissue.

DBM putty offers a range of advantages over traditional autografts (bone grafts harvested from the patient’s own body) and allografts (bone grafts sourced from cadavers). Its osteoconductive nature allows it to seamlessly integrate with the surrounding bone, while its osteoinductive capacity stimulates the production of bone-forming proteins, accelerating the healing process.

The biocompatible carrier in which DBM putty is incorporated plays a crucial role in its moldable and easy-to-form nature. This carrier, typically a combination of collagen and alginate, provides the putty with its desired consistency, allowing surgeons to precisely shape and contour it to fill bone voids of various sizes and configurations. The carrier also contributes to the overall bioactivity of DBM putty, enhancing its ability to promote bone regeneration.

Particulated Bone

Particulated bone allografts, derived from human bone tissue, are biomaterials used to fill bone defects and promote bone regeneration. They come in various particle sizes, each offering unique properties and applications.

Powdered allografts, the smallest particles, possess high integration capabilities and are suitable for small defects. Granule and crushed allografts are larger in size, serving as a foundation for bone regeneration and can be used as fillers or for augmentation.

Chip allografts, the largest among particulated bone grafts, provide a bone scaffold, making them ideal for larger defects or augmentation.

Pre-Shaped Bone

Bone grafting using Cube, Matchstick and Block forms has revolutionized orthopedic and maxillofacial surgeries, offering distinct advantages due to their unique compositions. Cube and Matchstick configurations consist solely of cancellous bone, while block formations comprise a core of cancellous bone enveloped by a cortical surface. These allograft are meticulously processed to decellularization and ensure sterilization. The resulting grafts provide essential structural support and seamlessly integrate with the recipient’s bone, promoting the formation of new bone. Cube and block bone allografts effectively address osseous deficiencies caused by various conditions, from post-traumatic injuries to degenerative diseases and reconstructive procedures. In dental implantology, they serve as a reliable scaffold for augmenting deficient mandible and maxilla structures and facilitating successful implant placement. Moreover, in reconstruction surgeries, these grafts significantly contribute to restoring maxillofascial and skeletal, enabling patients to regain both physical form and function. Ongoing refinement of bone grafting techniques, along with continued research and innovation, will further enhance the applications and outcomes of cube and block bone allografts, elevating the standard of care in orthopedic and maxillofacial surgeries.

Tendon & Meniscus

Tendon allografts offer a valuable solution when a patient’s tendon is teared or damaged. These allografts have revolutionized orthopedic practices, providing remarkable advantages in tendon reconstruction. Processed under aseptic conditions and preserved through cryopreservation at -80ºC, these allografts exhibit exceptional structural integrity and possess the ability of tendon reconstruction. The aseptic processing techniques employed during procurement and processing ensure the preservation of allograft quality, minimizing the risk of contamination. This products are as a great solution in sport medicine surgeries such as ACL,PCL and total and subtotal menisectomy.

Bone Shaft

The allograft heart valve product is derived from a cadaveric donated heart 48h after cardiac arrest. Prior to retrieving the whole heart from a mortuary or dedicated donation suite, the donor screening in case of age limitation (1 to 55 years old), medical history, and physical examination is performed. Then, the valve is carefully dissected from the heart in a licensed pharmaceutical grade cleanroom (GMP classification B) to remove excess myocardium, fat, and connective tissue. At this stage, the valve is treated with an antibiotic cocktail to reduce the bioburden. It should also be noted that in order to assure the product safety, several quality control tests such as microbiologic & serologic assays are carried out; each sample is tested for aerobic and anaerobic bacteria, fungi & HIV antibodies type 1, 2 (anti- HIV1&2), antibody to human T-lymphotropic virus type 1,2 (HTLV Ab1,2), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCVAb), Hepatitis B surface Antigen (HBsAg), and RPR for syphilis.

Bone Wedge

Bone wedge allografts are typically composed of dense cancellous bone with either no cortical ridges or a single/multiple cortical ridges. The cancellous bone provides a natural scaffold for bone ingrowth, while the cortical ridges provide additional structural support. Allogenic wedge bone grafts are a specific type of allogenic bone graft shaped like a triangle. They are commonly used in orthopedic surgeries to restore bone defects and provide structural support. One of the main uses of allogenic wedge bone grafts is in bone defect reconstruction. These grafts are often employed when there is a significant bone defect resulting from trauma, tumor resection, or congenital abnormalities. By filling in the missing bone, allogenic wedge bone grafts help restore the bone’s integrity and provide support for proper healing. Another application of allogenic wedge bone grafts is in corrective osteotomies. Corrective osteotomy procedures involve cutting and realigning a bone to correct deformities or malalignment. The use of allogenic wedge bone grafts can help maintain the corrected position and facilitate bone healing in these cases.

DBM Putty

Demineralized bone matrix (DBM) putty is a highly specialized bone graft material that has emerged as a valuable tool in the surgical management of bone defects. Derived from human or animal bone that has been processed to remove its mineral components, DBM putty presents a soft, malleable scaffold richly endowed with osteoconductive and osteoinductive properties. These properties enable DBM putty to serve as a platform for bone cell attachment, proliferation, and differentiation, fostering the regeneration of new bone tissue.

DBM putty offers a range of advantages over traditional autografts (bone grafts harvested from the patient’s own body) and allografts (bone grafts sourced from cadavers). Its osteoconductive nature allows it to seamlessly integrate with the surrounding bone, while its osteoinductive capacity stimulates the production of bone-forming proteins, accelerating the healing process.

The biocompatible carrier in which DBM putty is incorporated plays a crucial role in its moldable and easy-to-form nature. This carrier, typically a combination of collagen and alginate, provides the putty with its desired consistency, allowing surgeons to precisely shape and contour it to fill bone voids of various sizes and configurations. The carrier also contributes to the overall bioactivity of DBM putty, enhancing its ability to promote bone regeneration.

Particulated Bone

Particulated bone allografts, derived from human bone tissue, are biomaterials used to fill bone defects and promote bone regeneration. They come in various particle sizes, each offering unique properties and applications.

Powdered allografts, the smallest particles, possess high integration capabilities and are suitable for small defects. Granule and crushed allografts are larger in size, serving as a foundation for bone regeneration and can be used as fillers or for augmentation.

Chip allografts, the largest among particulated bone grafts, provide a bone scaffold, making them ideal for larger defects or augmentation.

Pre-Shaped Bone

Bone grafting using Cube, Matchstick and Block forms has revolutionized orthopedic and maxillofacial surgeries, offering distinct advantages due to their unique compositions. Cube and Matchstick configurations consist solely of cancellous bone, while block formations comprise a core of cancellous bone enveloped by a cortical surface. These allograft are meticulously processed to decellularization and ensure sterilization. The resulting grafts provide essential structural support and seamlessly integrate with the recipient’s bone, promoting the formation of new bone. Cube and block bone allografts effectively address osseous deficiencies caused by various conditions, from post-traumatic injuries to degenerative diseases and reconstructive procedures. In dental implantology, they serve as a reliable scaffold for augmenting deficient mandible and maxilla structures and facilitating successful implant placement. Moreover, in reconstruction surgeries, these grafts significantly contribute to restoring maxillofascial and skeletal, enabling patients to regain both physical form and function. Ongoing refinement of bone grafting techniques, along with continued research and innovation, will further enhance the applications and outcomes of cube and block bone allografts, elevating the standard of care in orthopedic and maxillofacial surgeries.

Tendon & Meniscus

Tendon allografts offer a valuable solution when a patient’s tendon is teared or damaged. These allografts have revolutionized orthopedic practices, providing remarkable advantages in tendon reconstruction. Processed under aseptic conditions and preserved through cryopreservation at -80ºC, these allografts exhibit exceptional structural integrity and possess the ability of tendon reconstruction. The aseptic processing techniques employed during procurement and processing ensure the preservation of allograft quality, minimizing the risk of contamination. This products are as a great solution in sport medicine surgeries such as ACL,PCL and total and subtotal menisectomy.

Orthopedic and Spine

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