Gel & Putty

Gel & Putty

OneFuse is a Patented combination of demineralized cortical bone, and a carrier. The carrier, in recent studies, “demonstrated advantageous properties in tissue engineering such as formation of pathways for induction of better cell migration, better delivery of nutrients and bioactive molecules to growing cells and better removal of their wastes, thus providing a better environment for tissue regeneration.” As a result OneFuse has a unique characteristic in that it has extremely high cohesiveness while having excellent hydrophilic qualities.

  • OneFuse Gel

    OneFuse Gel

  • OneFuse Putty

    OneFuse Putty

  • OneFuse Putty

    OneFuse Putty

  • OneFuse Putty

    Moldable

  • OneFuse Putty

    Stays Together

  • OneFuse Putty

    All Shapes

  • Quality Management System

    • ISO13485 certified
    • ISO class 5 clean rooms
    • FDA registered, complies with 21 CFR Part 1270 and 1271
    • AATB accredited

  • Products are in compliance with

    • FDA regulation, Title 21, Code of Federal Regulations Part 1271
    • Human Organs And Tissues Safety And Control Act [Partial modification on January 27, 2005 Act No. 7375]
    • Human Organs And Tissues Safety And Control Executive Order [Partial modification on July 3, 2006. Decree of Department of Health & Welfare No. 363]
    • Human Organ And Tissue Safety And Control Decree [Partial modification on June 12, 2006. Presidential Decree No.19513]
    • Decree No. 2005-16 Food & Drug Administration No. 2005-16

  • DBM Putty Benefits

    • Donor testing exceeds FDA and AATB criteria
    • High osteoinductivity (Each lot tested by In Vitro Assay)
    • Each lot is tested for BMP’s and growth factors (ELISA)
    • Superior handling/molding characteristics
    • High cohesiveness
    • Excellent hydrophilic qualities
    • Easily mixed with complimentary biologics
    • Room temperature storage
    • Comes ready to use
    • Electron beam sterilization

  • DBM Gel Benefits

    • Donor testing exceeds FDA and AATB criteria
    • High osteoinductivity (Each lot tested by In Vitro Assay)
    • Each lot is tested for BMP’s and growth factors (ELISA)
    • Excellent handling/ owable characteristics
    • High cohesiveness
    • Excellent hydrophilic qualities
    • Easily mixed with complimentary biologics
    • Room temperature storage
    • Comes ready to use
    • Electron beam sterilization

  • Indications

    • Compensation and reconstruction of autograft bone
    • Spine fixation with adequate materials
    • Bone fixation and lling in various sizes and forms of bone defect
    • Spinal fusion
    • Oncology
    • Joint revision
    • Long bone trauma
    • Distal fracture
    • Small bone procedure
    • Maxillofacial defect

    Dental Surgery

    Implantological Indications

    • Extraction site
    • Ridge preservation
    • Sinus oor elevation
    • Socket preservation
    • Wall defect
    • Torus
    • Fenestration defect
    • Dehiscence defect
    • Reconstruction of maxillofacial defect

    Periodontal Indications

    • Periodontal augmentation
    • Exposed implant
    • Periodontal defect
    • Esthetic augmentation

  • Contraindications

    OneFuse is not intended to provide structural support of the bone during the healing process and the following circumstances:

    • Uncontrolled diabetes
    • Severe degenerative bone disease
    • Active or latent infection in or about the surgical site
    • Renal impairment
    • Vascular disease
    • Neurological disease

  • Purpose

    Each lot of OneFuse is tested for BMP’s and growth factors (ELISA)

    • Samples from the same ten lots were tested per Protocol: BMP-2 ELISA. Each donor lot was tested in triplicate
    • BMP-2 concentration was mainly affected by individual factors (gender, age, health condition of donors). As reported in the literature, BMP-2 induces new bone formation at both bony and non-bony sites. A dose-related response was observed and reported as well: higher doses of rhBMP-2 yielded a faster formation of cartilage and bone
    • The BMP-2 concentration of OneFuse Plus was measured and a range of 42.48 ~ 123.50 ng BMP-2 in 1cc were detected by ELISA

  • Serological Testing

    Prior to donation all donor medical/social history is screened for medical conditions or diseases that would contraindicate the donation of tissue in accordance with the current regulations established by the FDA (21 CFR 1270) and standards set forth by AATB. All donor tissue utilized for processing is provided by recovery agencies registered with the FDA and accredited by AATB. Screening criteria exceeds requirements established by the FDA and AATB.

    Serological tests are performed in accordance to FDA regulations and AATB standards.

    In accordance with regulations set forth by the FDA and standards by AATB, donor blood samples are collected at the time of recovery and serological testing is performed on each tissue donor (see below) by a CLIA certificed laboratory.

    • Antibodies to the human immunodeciency virus, type 1 and type 2 anti-HIV-1 and anti-HIV-2
    • Nucleic acid test (NAT) for HIV-1
    • Hepatitis B surface antigen (HBsAg)
    • Total antibodies to hepatitis B core antigen anti-HBc-total, meaning IgG and IgM
    • Antibodies to the hepatitis C virus (anti-HCV)
    • Nucleic acid test (NAT) for HCV
    • Syphilis

  • OneFuse additional screening

    • Clinically significant metabolic bone disease
    • Gonorrhea (clinically active)
    • Illicit drug use, injected drugs
    • Leprosy (Hansen’s disease)
    • Polyarteritis nodosa
    • Rabies
    • Rheumatoid arthritis
    • Sarcoidosis
    • Systemic lupus erythematosus
    • Systemic mycosis
    • Tuberculosis (clinically active)
    • Active genital herpes
    • Cancer (see chart below)
    • Encephalitis (clinically active)
    • Endocarditis (clinically active)
    • High risk behavior
    • Illicit drug use, non-injected drugs
    • Meningitis (clinically active)
    • Multiple sclerosis
    • Poliomyelitis

    Tissue cultures collected during the recovery process are tested for the following microbial contaminants:

    • Aerobic
    • Anaerobic
    • Fungal

  • Viral Inactivation and Biocompatibility

    Tissue processing procedures have been validated to inactivate and eliminate the following viruses:

    • HIV-1 - Human immunodeciency virus type 1
    • BHV - Bovine herpes virus
    • BVDV - Bovine viral diarrhea virus
    • HAV - Hepatitis A virus
    • PPV - Porcine parvovirus

    OneFuse has undergone and passed the following series of standard tests relating to its biocompatibility:

    Cytotoxicity

    ISO 10993-5 To determined whether leachables extracted from the material would cause cytotoxicity

    Maximization/Hypersensitivity Testing

    ISO 10993 Part 10 2002(E) Tests for Irritation and Delayed-type Hypersensitivity

    Irritation/Intracutaneous Reactivity Testing

    ISO 10993 Part 10 2002(E) Tests for Irritation and Delayed-type Hypersensitivity

    Acute Systemic Toxicity Study in Mouse

    ISO10993 Part 11 2002(E) Test for Systemic Toxicity

    Muscle Implantation/Biological Suitability Testing in Rabbits

    USP 28[88] To evaluate the local effect of implanted OneFuse samples in the paravertebral muscle

    Implantation Test in Rabbit Bone

    ISO 10993-6 To evaluate the biocompatibility and local effect of OneFuse over a 12 week period

    Genotoxicity/Bacterial Reverse Mutation Assay (Ames Test)

    ISO 10993 Part 3 Test for Genotoxicity, Carcinogenicity and Reproductive Toxicity

    Hemolysis Testing

    ISO 10993-4 Test the interaction of OneFuse samples with rabbit blood

    Endotoxin Testing

    ISO 10993-12 To determine the level of endotoxin in the leachables extracted from the testing material

  • Carrier Information

    Carboxymethyl Cellulose (CMC)

    Is sodium salt of carboxymethyl cellulose. It is derived from cellulose, which is made water-soluble by a chemical reaction. The water-solubility is achieved by introducing carboxymethyl groups along the cellulose chain, which makes hydration of the molecule possible. CMC is used as a viscosity modifer or thickener, and to stabilize emulsions in various products. CMC is also known for its excellent water retaining capacity.

    Studies have shown that porous CMC scaolds demonstrated advantageous properties in tissue engineering such as formation of pathways for induction of better cell migration, better delivery of nutrients and bioactive molecules to growing cells and better removal of their wastes, thus providing a better environment for tissue regeneration.[1]

    1. HWang CM, Sant S, Masaeli M, Kachouie NN, Zamanian B, Lee SH, et al. Fabrication of three-dimensional porous cell-laden hydrogel for tissue engineering. Biofabrication. 2010;2:035003 (12 pp)

  • Fusion Study


    Radiographs of a rabbit spine after posterolateral lumbar arthrodesis using OneFuse

    Purpose

    The study was conducted to verify the effectiveness of spinal fusion with OneFuse and its ability to stimulate new bone formation.

    Summary

    The spinal fusion models of rabbits were prepared following posterolateral intertransverse process arthrodesis bilaterally at L4-L5 section of the lumbar vertebrae. Equivalent amounts of OneFuse Plus putty and gel and the industry leading DBM (control) were implanted into each model. The ability of OneFuse to stimulate new bone formation and interbody spinal fusion as evaluated at 4, 8 and 13 weeks after implantation by conducting a longitudinal radiologic evaluation, biomechanical and histology test. The rabbits models were evaluated for radiologic findings, fusion rate, biomechanical strength and histological findings (graft material residue rate, new bone formation rate). The results indicate biocompatibility and proved a gradual density growth along with successful bone remodeling. Fusion was observed after 13 weeks in the L4-L5 section. In histological evaluation, compact one continuity was noted following a progressive activation of new osteoid tissue and bone marrow cavity formation.

    Conclusion

    OneFuse has an equivalent effect when compared to the industry leading DBM.

  • Osteinductivity Study


    Each lot is tested for osteoinductivity (In Vitro Assay)
    Each lot of OneFuse is tested for BMP’s and growth factors (ELISA)

    Purpose

    The study was conducted to evaluate OneFuse originating from multiple donors.

    Summary

    In Vitro Assay

    • The OneFuse samples used for this evaluation originated from ten different donors. The units were sterilized by electron beam
    • Samples from the same ten lots were tested per Protocol: BMP-2 ELISA. Each donor lot was tested in triplicate
    • P-2 concentration as mainly a ected y indi idual factors gender and age . As reported in the literature, BMP-2 induces new bone formation at both bony and non-bony sites. [6.1] A dose-related response was observed and reported as well: higher doses of rhBMP-2 yielded a faster formation of cartilage and bone
    • The BMP-2 concentration of OneFuse was measured

    In Vitro Assay

    • Samples from the same ten lots were implanted per Protocol: In vivo Osteoinductivity Assessment using an Ectopic Bone Formation Model. Each lot of tissue was implanted into three mice with each mouse receiving approximately 0.3cc of OneFuse
    • After 28 days, the mice were sacrificed
    • Slides were prepared and examined using various methods including immunology and histology

    Conclusions

    OneFuse was transplanted in the hip muscle of an athymic rat, and several histological tests were performed for evaluation of osteoinductive ability. Consequently, the recruitment of osteoblasts and osteoclasts in the sites which contribute to osteogenesis were observed. The osteoblasts which were observed in the site might be interpreted as DBM being degraded to form new bone. The results show that OneFuse has high osteoinductive capacity in a mouse model, contributing to new bone formation in bone-defective regions.

  • Volume & Order Number

    Putty

    1.0cc (TCDBM-P1)
    3.0cc (TCDBM-P3)
    5.0cc (TCDBM-P5)
    10.0cc (TCDBM-P10)

    Gel

    1.0cc (TCDBM-G1)
    3.0cc (TCDBM-G3)
    5.0cc (TCDBM-G5)
    10.0cc (TCDBM-G10)

  • Download Brochure

    Download Brochure

Hours

Mon-Fri 9am - 5:00pm
Sat 9am - 1pm
Sun Closed

About Us

Tisucor is a provider of Human Allograft Tissue Products derived from their original state resulting in safe, high quality tissue. Tissue from accredited tissue banks are registered with the U.S. Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks.
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