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Bone Graft Manufacturers

Last updated: March 2026

This directory lists 74 bone graft manufacturers across the United States, from specialized human tissue banks focusing on allograft processing to advanced biomaterial producers fabricating synthetic graft scaffolds.

Buyers are typically solving critical supply chain challenges, whether it's ensuring a reliable source of demineralized bone matrix (DBM), scaling up production of complex xenograft constructs, or finding a partner capable of developing novel osteoinductive synthetic bone void fillers that meet specific surgical application needs. The demand for highly specialized processing, often involving intricate lyophilization or specialized coating techniques, dictates the choice of partner.

Supplier types in this space broadly fall into a few categories: dedicated human tissue processing facilities (often AATB accredited), synthetic biomaterial manufacturers with expertise in calcium phosphate or polymer composites, and integrated contract manufacturers offering services across both allograft and synthetic formulations. Each type brings distinct advantages in raw material access, processing capabilities, and regulatory expertise for different graft modalities.

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Company Directory

74 companies nationwide

Berkeley Biologics LLC

Berkeley Biologics LLC operates as a contract manufacturer, providing comprehensive turnkey services for partners. The company specializes in offering private-label allograft opportunities, including custom solutions for specialized tissue processing and manufacturing within the biologics sector.

Email availablePhone available

Dimensional Bioceramics, LLC

Santa Cruz, CA

Based in Santa Cruz, CA, Dimensional Bioceramics, LLC specializes in the development and manufacturing of bioceramic medical devices. The company produces DB-EZ Bone Void Filler, an FDA 510(k)-cleared product designed for orthopedic applications and bone void filling procedures.

Email availablePhone available

Alamo Biologics

San Antonio, TX

Based in San Antonio, TX, Alamo Biologics operates as a full-service tissue bank. The company provides high-quality allografts and biologics, specializing in the processing, storage, and distribution of donor tissue. Their mission focuses on honoring tissue donation and providing healing allografts to recipients.

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AlloSource

Centennial, CO

Based in Centennial, CO, AlloSource is a human tissue provider specializing in innovative allografts. They create dermis, cartilage, tendon, fascia, bone, and amnion products, including bone and amnion allografts used in various spine procedures.

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Anika Therapeutics, Inc.

Anika Therapeutics, Inc. specializes in hyaluronic acid-driven regenerative solutions, manufacturing medical devices like Tactoset. This biocompatible, calcium phosphate injectable bone substitute is utilized for treating insufficiency fractures and augmenting hardware. The company also offers the Integrity Implant System for tendon repair applications.

Email availablePhone available

ATEC Spine, Inc.

Carlsbad, CA

ATEC Spine, Inc. develops and manufactures medical devices for spine surgery. Their product portfolio includes porous titanium interbody spacers and AlphaGRAFT DBM Fibers, a demineralized bone matrix (DBM) product offering an osteoconductive scaffold made of 100% demineralized fibers for orthopedic procedures.

Email availablePhone available

Baxter

Deerfield, IL

Baxter is a global healthcare company that develops, manufactures, and markets a broad portfolio of medical products. They directly provide bone graft manufacturing services, including their U.S. FDA-cleared synthetic bone graft substitute, Actifuse Flow. Baxter serves healthcare providers and patients with innovative solutions.

Email availablePhone available

Berkeley Biologics

Richmond, CA

Berkeley Biologics is a contract manufacturer of orthopedic and spinal allografts. Based in Richmond, CA, they offer turnkey services and private-label opportunities, supporting custom product development, processing, and distribution. The company operates an FDA-registered, AATB-accredited facility, providing comprehensive solutions for the biologics industry.

Email availablePhone available

Bioventus

Cordova, TN

Based in Cordova, TN, Bioventus delivers innovative surgical orthobiologics and active healing solutions for orthopedic care. The company provides a comprehensive portfolio of clinically efficacious and cost-effective biologic therapies for patients, physicians, and payers.

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Bioventus Surgical

Bioventus Surgical manufactures a comprehensive portfolio of surgical orthobiologics, providing a variety of bone graft solutions for surgeons and patients. They focus on advancing orthobiologic science and surgical performance, delivering clinically efficacious and cost-effective products like OSTEOAMP SELECT Flowable, a 100% allograft.

Email availablePhone available

Bone Bank Allografts

San Antonio, TX

Based in San Antonio, TX, Bone Bank Allografts provides regenerative medicine technologies and allograft tissue products. The company processes tissue donations, offering sterile bone and soft tissue allografts, including demineralized bone matrix, cortical bone fibers, and specialty custom products. They serve the surgical community with solutions for healing and recovery.

Email availablePhone available

Avtec Surgical

Mount Pleasant, SC

Avtec Surgical, based in Mount Pleasant, SC, specializes in manufacturing advanced bone graft solutions. The company produces Demineralized Bone Matrix (DBM) Crunch, a pure bone tissue product with a larger particulate size. Their DBM contains no carrier or filler, providing an effective option for bone regeneration procedures.

Email availablePhone available

Cerapedics

Westminster, CO

Cerapedics manufactures advanced bone graft solutions and bone growth accelerators. Their portfolio includes FDA-approved PearlMatrix™ P-15 Peptide Enhanced Bone Graft for lumbar spine fusion and i-FACTOR® P-15 Peptide Enhanced Bone Graft for ACDF. The company emphasizes rigorous clinical evidence to advance spine surgery.

Email availablePhone available

Dentium USA

Cypress, CA

Based in Cypress, CA, Dentium USA manufactures advanced synthetic osteoconductive bone graft materials. Their Osteon III product offers excellent wettability and a porous structure, designed to facilitate bone regeneration. These solutions improve patient outcomes for immediate implantation and other sophisticated dental applications, supporting optimal treatment.

Email availablePhone available

Hiossen Implant USA

Ridgefield Park, NJ

Based in Ridgefield Park, NJ, Hiossen Implant USA manufactures dental implants, prosthetic kits, and various surgical tools. The company also produces A-Graft Deproteinized Bovine Bone (DBB) bone graft materials, supplying essential products for oral and maxillofacial surgical procedures.

Email availablePhone available

Geistlich Pharma North America Inc.

Princeton, NJ

Based in Princeton, NJ, Geistlich Pharma North America Inc. specializes in manufacturing regenerative medical devices and biomaterials for bone, cartilage, and tissue regeneration. The company provides naturally sourced biomaterials for predictable clinical outcomes, primarily serving dental, surgical, and sports medicine professionals with advanced regenerative solutions.

Email availablePhone available

Geistlich

Princeton, NJ

Based in Princeton, NJ, Geistlich develops and manufactures biomaterial solutions for dental professionals. The company specializes in regenerative dentistry products, including bone substitutes like Bio-Oss® and collagen membranes such as Bio-Gide®, used for guided bone and tissue regeneration.

Email availablePhone available

Glidewell Dental

Newport Beach, CA

Glidewell Dental, based in Newport Beach, CA, specializes in advanced dental solutions. They offer digital dentistry, restorative solutions, implants, and biologics, including bone allografts. The company provides in-office technologies for designing, milling, and delivering dental restorations, emphasizing their manufacturing capabilities for various dental products.

Email availablePhone available

Glidewell Direct

Irvine, CA

Based in Irvine, CA, Glidewell Direct manufactures high-quality regenerative products for various grafting indications. The company also produces a range of dental solutions including BruxZir Solid Zirconia and Glidewell HT Implants from titanium alloy, serving clinicians globally.

Email availablePhone available

Globus Medical

Carrollton, OH

Globus Medical, based in Carrollton, OH, manufactures a comprehensive portfolio of biologics for musculoskeletal conditions. Their offerings include cellular allografts, synthetic bone void fillers, and demineralized bone products. The company develops integrated solutions and enabling technologies to improve patient care.

Email availablePhone available

Hans Medical

Chatsworth, CA

Based in Chatsworth, CA, Hans Medical provides demineralized bone fibers, branded as AlloGraft Plus, for osteoinduction and osteoconduction. These bone graft products feature a unique fibrous network engineered for excellent osteoconductive potential and retention properties, serving various medical applications.

Email availablePhone available

HDA Technology

Oceanside, CA

Based in Oceanside, CA, HDA Technology provides custom medical device development and manufacturing, specializing in orthopedic and spinal applications. Services include product design, prototyping, CNC machining, injection molding, cleanroom assembly, sterilization, and packaging solutions for various medical devices.

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HIMED

Old Bethpage, NY

Based in Old Bethpage, NY, HIMED manufactures medical-grade calcium phosphate powders, granules, and hydroxyapatite. These biomaterials are supplied to medical device manufacturers for applications like dental implants, bone fillers, and synthetic bone grafts. HIMED enhances designs with osseoconductive properties for various medical applications.

Email availablePhone available

Implant Direct

Thousand Oaks, CA

Based in Thousand Oaks, CA, Implant Direct manufactures dental implant solutions. The company provides diverse implant systems and biomaterials, including DirectGen™ DBM Putty for bone grafting in dental procedures. They focus on delivering high-quality products to clinicians, enhancing patient access to predictable outcomes.

Email availablePhone available

Induce Biologics Inc.

Anaheim, CA

Based in Anaheim, CA, Induce Biologics Inc. develops and manufactures novel osteobiologic products. The company leverages Natural Matrix Protein (NMP) technology to create bioimplants for orthopedic, dental, and spinal applications, effectively stimulating natural bone regeneration processes for enhanced healing.

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JRF Ortho

San Leandro, CA

Based in San Leandro, CA, JRF Ortho is a specialized company and supplier of fresh osteochondral allografts. They have provided over 20,000 fresh OCA grafts since 2006, focusing on cartilage restoration and advancing orthopedic techniques.

Email availablePhone available

Keystone Dental Group

Keystone Dental Group offers dental solutions, specializing in tissue regeneration and biomaterials. The company provides a range of products, including bone graft materials such as DynaGraft-D Putty and SG Granule, for dental professionals. It supports various dental applications through its online eShop.

Email availablePhone available

Kinamed

New Orleans, LA

Based in New Orleans, LA, Kinamed manufactures advanced medical devices for orthopedic and neurosurgical applications. Their product portfolio includes OsteoRepair, a next-generation calcium phosphate cement for bone repair, alongside bone preparation systems, patient-matched replacement devices, and specialized fixation products for surgical procedures.

Email availablePhone available

Nobel Biocare

Nobel Biocare manufactures xenogenic bone substitutes for guided bone regeneration (GBR) and guided tissue regeneration (GTR). Their regenerative portfolio supports dental implant procedures, including solutions for site preparation and innovative restorative designs. The company provides digital workflows to enhance esthetic zone and full-arch treatments for clinicians.

Email availablePhone available

NovaBone

Atlanta, GA

NovaBone is a biotechnology company specializing in developing and manufacturing advanced biomaterials. They focus on products for bone and soft tissue regeneration, catering to the specialized needs of dental and orthopedic surgeons. Their offerings include bone grafts, dental putties, and wound matrices.

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NuVasive

San Diego, CA

Based in San Diego, California, NuVasive manufactures advanced biologics, including allogeneic bone graft substitutes and extenders for spinal procedures. Their portfolio also features synthetic ceramic bone graft substitutes, contributing to innovative orthopedic solutions. The company is currently transitioning its operations to Globus Medical.

Email availablePhone available

NVISION Bio Medical Technologies

San Antonio, TX

Based in San Antonio, TX, NVISION Bio Medical Technologies is a medical device and biologics company. It provides surgeons with innovative implants and biologics designed to simplify and improve surgical procedures. The company offers products for spine and extremities, committed to high-quality orthopedic solutions for treatment and diagnosis.

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OrthoPediatrics Corp.

Warsaw, IN

Based in Warsaw, IN, OrthoPediatrics Corp. designs and manufactures specialized orthopedic products for pediatric patients. Their comprehensive offerings include solutions for trauma, deformity correction, and external fixation. The company also produces CERAMENT BONE VOID FILLER, a synthetic bone graft substitute for bone regeneration in children.

Email availablePhone available

OSSIO Inc

Based in Woburn, MA, OSSIO Inc manufactures bio-integrative orthopedic implants using its proprietary OSSIO fiber® material. These implants, composed of natural bone minerals, are designed to securely fixate, fully integrate into native bone, and restore strength without permanent metal hardware.

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Parametrics Medical

Leander, TX

Based in Leander, TX, Parametrics Medical provides a comprehensive portfolio of biologic solutions, including allograft tissue and biologic implants. Specializing in regenerative medicine, the company serves sports medicine, wound care, and various orthopedic specialties such as spine, extremities, and oral surgery. They hold tissue processing credentials for advanced patient care.

Email availablePhone available

Pinnacle Transplant Technologies

Phoenix, AZ

Pinnacle Transplant Technologies, based in Phoenix, AZ, manufactures high-quality allograft implants. They produce precision-machined grafts, demineralized bone matrix/fibers (DBM/DBF), and allograft chips. These solutions serve Spine, Sports Medicine, Orthopedics, Trauma, Dental, and Wound Care, with tissue prepared through extensive testing and validated sterilization processes.

Email availablePhone available

restor3d

restor3d manufactures personalized, 3D-printed orthopedic implants for reconstructive surgery. They leverage proprietary osseointegrative materials and AI-based design automation to create patient-specific solutions. These implants are tailored to individual anatomies, optimizing surgical outcomes and facilitating bone integration.

Email availablePhone available

Royal Biologics Inc.

Hackensack, NJ

Based in Hackensack, NJ, Royal Biologics Inc. develops orthobiologic and life science solutions for enhancing healing. The company focuses on autologous and live cellular therapies to address musculoskeletal and regenerative medicine challenges through a comprehensive product portfolio. Offerings include surgical products and wound care solutions.

Email availablePhone available

SigmaGraft Biomaterials, Inc.

Fullerton, CA

Based in Fullerton, CA, SigmaGraft Biomaterials, Inc. manufactures high-quality biomaterials for dental and orthopedic surgeries. They specialize in innovative bone substitutes, allografts, xenografts, and resorbable membranes used for bone and tissue regeneration. The company focuses on research, development, and production of these products.

Email availablePhone available

SolcoAmerica

Carrollton, TX

SolcoAmerica manufactures synthetic bone grafts, including synthetic strips made from purified fibrillar collagen and resorbable ceramic granules. These grafts are designed to be resorbed and replaced by natural bone. The company offers biologics for cervical, thoracolumbar, and kyphoplasty applications.

Email availablePhone available

SurGenTec, LLC

Boca Raton, FL

Based in Boca Raton, FL, SurGenTec, LLC is a medical device company focused on products for spine and orthopedic surgeries. They manufacture bone graft materials, including NanoPutty, HydroPutty, and HydroFiber, and develop innovative bone graft delivery devices. The company aims to enhance patient quality of life.

Email availablePhone available

Surgical Esthetics Biomedical Technologies, Inc.

Surgical Esthetics Biomedical Technologies, Inc. manufactures and supplies bone graft and allograft products, alongside other dental regenerative biomaterials. Their offerings include membranes, collagen, sutures, and implant instruments. Serving general dentists and specialists, the company focuses on high-quality products for optimal patient healing.

Email availablePhone available

Ultradent Products

South Jordan, UT

Ultradent Products manufactures a diverse range of dental solutions, including OsteoGen® Bone Grafting Plugs, directly serving the bone graft sector. Based in South Jordan, UT, their product line also features Opalescence teeth whitening systems, etchants, fluoride varnish, and universal bond adhesives for improving global oral health.

Email availablePhone available

Unicare Biomedical Inc.

Laguna Hills, CA

Based in Laguna Hills, CA, Unicare Biomedical Inc. designs, develops, manufactures, and distributes innovative wound care and tissue regeneration solutions. The company provides bone grafts, membranes, and hemostats for dental and orthopedic professionals, adhering to ISO 13485 quality standards.

Email availablePhone available

Purgo Biologics Inc

Purgo Biologics develops advanced biomaterials for soft tissue and bone regeneration in oral healthcare. The company manufactures bone grafts, including THE Graft™ Collagen, a porcine-derived bone mineral matrix and collagenated bone block for dental applications. It focuses on solutions for alveolar ridge preservation and GBR success.

Email availablePhone available

Xtant Medical

Belgrade, MT

Based in Belgrade, MT, Xtant Medical develops and provides orthobiologic solutions, including bone grafts, and complementary spinal implant systems. As a vertically integrated tissue bank, the company offers scientifically engineered biologics for a wide range of surgical procedures, empowering surgeons and improving patient outcomes.

Email availablePhone available

Zimmer Biomet

Warsaw, IN

Zimmer Biomet manufactures medical solutions, including products specifically for bone grafting and autologous therapies. The company offers a range of solutions for hard and soft tissue applications, focusing on enhancing patient mobility, joint health, and overall wellness. Their offerings support various orthopedic and reconstructive procedures.

Email availablePhone available

ZimVie Inc.

Austin, TX

Based in Austin, TX, ZimVie Inc. provides clinically proven solutions for dental implantology. The company manufactures biomaterials, including Puros® Allograft Bone Grafts, alongside dental implant systems and digital solutions. ZimVie's offerings aim to simplify procedures and enhance outcomes for dental practices.

Email availablePhone available

Dentis USA

Cypress, CA

Dentis USA provides a versatile range of allograft bone products for diverse surgical needs. Their offerings include a balanced 50% cortical/50% cancellous blend and 100% cortical bone. As a biomaterials provider, they aim to improve clinical outcomes with their advanced dental innovations and solutions.

Email available

KLS Martin Manufacturing LLC

Jacksonville, FL

Based in Jacksonville, FL, KLS Martin Manufacturing LLC develops and distributes comprehensive medical technology solutions. The company specializes in implant systems, high-frequency surgical devices, and surgical instruments, serving the surgical industry since 1896. They provide advanced medical devices, including individual patient solutions relevant to bone graft procedures.

Email available

Medtronic

Medtronic is a global medical technology company that manufactures a wide range of products, including spine and orthopedic solutions. They provide synthetic bone graft substitutes designed to support bone fusion and regeneration in various surgical applications for healthcare systems.

Email available

MTF Biologics

MTF Biologics processes high-quality allograft tissues for diverse clinical applications, including reconstructive surgeries, sports medicine, aesthetics, and chronic wound care. For nearly 40 years, the company has advanced tissue transplantation science, providing safe allograft options to surgeons and patients.

Email available

Neoss

Based in Westborough, MA, Neoss manufactures NeoGenix Extraction Allograft, a 100% human allograft fiber. Made from demineralized bone fibers, this product is engineered for optimal bone regeneration. Neoss also provides intelligent dental solutions and implant systems for professionals, supporting predictable patient outcomes.

Email available

Regenity Biosciences

Paramus, NJ

Regenity Biosciences, based in Paramus, NJ, is a contract development and manufacturing provider specializing in bioresorbable technologies for tissue and bone repair. They offer expertise in collagen, bioceramics, and synthetic polymers, with FDA-registered and ISO 13485-certified facilities. Their services support complex regenerative technologies for dental, spine, and orthopedic applications.

Email available

Stryker

Weston, FL

Stryker manufactures synthetic bone graft substitutes, including Vitoss, which features a unique interconnected, ultra-porous structure designed to resemble human cancellous bone. This medical technology company provides solutions for various orthopedic and spinal fusion procedures.

Email available

Subchondral Solutions

Costa Mesa, CA

Subchondral Solutions manufactures the S-Core® implant system, a medical device for structural repair and stabilization of insufficient subchondral bone. The S-Core® implant addresses trabecular fractures and osteochondritis, promoting bone integration and secure fixation for soft tissue augmentation below the hyaline cartilage surface.

Email available

BioHorizons

Birmingham, AL

Based in Birmingham, AL, BioHorizons manufactures a comprehensive range of dental products, specializing in bone grafting materials, membranes, soft tissue, and wound dressing solutions. The company also produces dental implants and offers digital solutions for dental professionals throughout the United States.

Phone available

BioPoly

Fort Wayne, IN

BioPoly develops and manufactures innovative orthopedic implants from a unique biomaterial that combines hyaluronic acid and polyethylene. This revolutionary biomaterial provides an early-stage solution to restore joint function and improve quality of life. The company focuses on advancing materials for effective joint repair.

Phone available

Evolve Manufacturing

Fremont, CA

Based in Fremont, CA, Evolve Manufacturing specializes in complex medical and life sciences device contract manufacturing. They offer precision machining, plastic and polymer fabrication, welding, and cleanroom assembly. The company works with biocompatible materials to produce high-quality components and finished instruments for the medical industry.

Phone available

Impladent Ltd.

Impladent Ltd. based in Northborough, MA, manufactures and distributes regenerative dental products. The company specializes in synthetic resorbable bone grafts, including OsteoGen® Plugs, Strips, and Malleable Bone Blocks. They also offer Collaform® absorbable collagen and OsteoFlex® membranes for dental procedures.

Phone available

LifeLink Tissue Bank

Tampa, FL

Based in Tampa, FL, LifeLink Tissue Bank operates a 54,000 square foot facility dedicated to processing human tissue. They prepare and provide allograft tissue for transplantation, including various forms of bone grafts. The organization focuses on tissue donation, processing, and distribution for surgical applications.

Phone available

LifeNet Health

Virginia Beach, VA

Based in Virginia Beach, VA, LifeNet Health processes human allograft biologic implants, providing surgeons with crucial tools for patient care. They specialize in tissue-based solutions, including bone grafts and products like Dermacell® Porous for wound management, advancing medical innovation and patient outcomes.

Phone available

Maxxeus

Kettering, OH

Based in Kettering, OH, Maxxeus manufactures musculoskeletal tissue grafts and biologic solutions for orthopedic, sports medicine, burn care, and dental fields. They provide allograft particulates, demineralized bone matrix (DBM) fillers, and structural grafts, processing tissues recovered across the United States.

Phone available

Osteogenics Biomedical

Lubbock, TX

Based in Lubbock, TX, Osteogenics Biomedical provides advanced tissue regeneration and implant placement solutions. The company offers products for guided bone regeneration, including high-density PTFE membranes and aorganic bovine bone-derived minerals. These materials are utilized for socket preservation and vertical augmentation of deficient alveolar ridges.

Phone available

Spinal Elements, Inc.

Carlsbad, CA

Based in Carlsbad, CA, Spinal Elements, Inc. innovates and manufactures differentiated spine technologies. They specialize in advanced biologics, providing patient-centric solutions for spine surgery. Their proprietary offerings include various bone graft solutions designed to improve patient care and address complex surgical challenges.

Phone available

Stability Biologics

San Antonio, TX

Stability Biologics, based in San Antonio, TX, manufactures advanced biologic products for regenerative medicine. Operating from a state-of-the-art facility, they process ethically sourced human tissue. Their portfolio includes specific bone graft materials like cortical fibers and cancellous chips, designed for a wide range of clinical applications.

Phone available

WishBone Medical

Warsaw, IN

Based in Warsaw, IN, WishBone Medical is a pediatric orthopedic company specializing in anatomically appropriate implants and instruments. They provide single-use, sterile packed procedure kits, including magnesium-based bone void fillers, for children suffering from orthopedic issues.

Phone available

Enovis

Enovis manufactures advanced bone graft solutions, including MatrixCellect® 100 DPM Putty. This demineralized bone matrix putty, derived from human bone with no added carriers, is engineered for homologous use in medical applications. The company develops products for surgeons and medical professionals.

No contact on file

HighRidge Medical

HighRidge Medical manufactures a comprehensive portfolio of spine solutions, including synthetic bone graft materials like CopiOs Bone Void Filler Paste and allograft options such as PrimaGen Advanced™. The company also provides various interbody and spinal fixation systems, supporting innovation in spine surgery.

No contact on file

Integra LifeSciences

Princeton, NJ

Integra LifeSciences develops and manufactures a diverse portfolio of medical technologies and devices for surgeons and clinicians worldwide. The company provides a range of products, including bone grafts and bone graft substitutes like the Mozaik™ line, which are used to aid and promote bone growth in surgical applications.

No contact on file

Isto Biologics

Isto Biologics, headquartered in Andover, MA, specializes in the development and commercialization of bone graft solutions. They offer consistent and cost-effective synthetic bone graft options, designed to aid the supply of autograft bone in the body and facilitate faster patient healing within the orthopedics sector.

No contact on file

Merz Biomaterials

Sturtevant, WI

Merz Biomaterials manufactures high-purity calcium hydroxyapatite (CaHA) for medical and dental applications in the United States. They supply this biocompatible ceramic for bone void filler and fixation products, implant coatings, and injectable implants. Merz customizes material specifications to meet diverse customer needs.

No contact on file

Redline Surgical

San Diego, CA

Redline Surgical, based in San Diego, CA, provides innovative solutions for spine surgery. They offer the VENADO Foam Strips Bone Graft System, a sterile bone graft combining purified fibrillar collagen with synthetic ceramic granules. The company focuses on operating room innovations and partners with medical technology firms for advanced spinal care.

No contact on file

RevBio Inc.

Based in Lowell, MA, RevBio Inc. develops TETRANITE®, a revolutionary synthetic bone adhesive inspired by the sandcastle worm. This biocompatible biomaterial transforms into a cement-like adhesive scaffold, providing wet field performance for bone-to-bone and bone-to-metal applications, promising to transform bone repair.

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How to Choose a Company

  • Verify AATB Accreditation and Tissue Traceability: For allograft or DBM products, meticulously confirm the manufacturer's AATB accreditation status and their robust system for donor screening, tissue recovery, processing, and comprehensive traceability from donor to recipient. A lapse here is an immediate red flag.
  • Assess Sterilization Validation Protocols: Scrutinize their sterilization methods (e.g., gamma irradiation, E-beam, ethylene oxide for terminal sterilization; or aseptic processing for sensitive materials) and demand evidence of rigorous validation protocols, ensuring sterility assurance levels (SAL) are appropriate for your specific graft type and intended use.
  • Evaluate Biomaterial Expertise and Customization Capabilities: Determine if they possess deep expertise in your desired biomaterial — whether it's hydroxyapatite, beta-TCP, collagen, or polymer blends — and if they can customize porosity, strength, or degradation profiles to match specific anatomical or clinical requirements for osteointegration.
  • Demand Comprehensive Regulatory Compliance Documentation: Ensure their Quality Management System (QMS) not only adheres to ISO 13485 and 21 CFR Part 820 but also provides clear documentation for predicate devices, 510(k) submissions, and post-market surveillance. A manufacturer unable to provide detailed regulatory dossiers is a significant risk.
  • Beware of "All-in-One" Claims without Specific Validation: A common pitfall for first-time buyers is partnering with a manufacturer claiming expertise across all graft types (allograft, xenograft, synthetic) without specific, verifiable validation data, processing lines, and regulatory pathways for each. Demand concrete examples and site visit confirmations for each modality.
  • Analyze Supply Chain Resilience for Raw Materials: Inquire about their strategies for managing raw material supply – particularly for human or animal-derived tissues – including redundant sourcing, inventory management, and contingency plans to mitigate disruptions, given the often sensitive and finite nature of these inputs.

Supplier Types at a Glance

TypeBest ForTypical MOQ
Human Tissue Banks (AATB Accredited)Allograft and DBM products, donor tissue processing for human boneVariable, often project-based for specific tissue types
Synthetic Biomaterial SpecialistsCustom calcium phosphate, polymer, or ceramic grafts; novel scaffold designs; xenograft processingModerate to High (e.g., 500-5000 units for custom formulations)
Integrated Contract ManufacturersBlended synthetic-allograft products, DBM carriers, scaling existing graft designs with diverse material needsHigh (e.g., 1000-10000+ units, depending on complexity)
Cellular Bone Matrix (CBM) ProcessorsViable tissue products, combination products with cellular components, advanced regenerative solutions requiring live cellsSmall to Moderate, highly specialized processes

Frequently Asked Questions

What is the primary difference in regulatory oversight for allograft vs. synthetic bone grafts?

Allograft bone grafts derived from human tissue are typically regulated by the FDA under 21 CFR Part 1271 as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), often requiring registration and listing. Synthetic bone grafts, conversely, are typically regulated as medical devices under 21 CFR Part 820, requiring 510(k) clearance or PMA approval depending on their classification and risk profile. Understanding this distinction is crucial for your submission strategy.

How critical is a bone graft manufacturer's AATB accreditation for my product?

AATB (American Association of Tissue Banks) accreditation is paramount if your product incorporates human-derived allograft tissue. While not a direct FDA requirement, it signifies adherence to stringent voluntary standards for donor screening, tissue recovery, processing, storage, and distribution that often exceed baseline regulatory requirements, providing an essential layer of quality assurance and reducing your compliance risk significantly.

Beyond standard ISO 13485, what specific quality system elements should I scrutinize for DBM or CBM manufacturers?

For Demineralized Bone Matrix (DBM) or Cellular Bone Matrix (CBM) products, pay close attention to the manufacturer's validated processes for demineralization consistency, growth factor retention, terminal or aseptic processing, and donor screening criteria. CBM, specifically, demands inquiry into cell viability assays, cryopreservation protocols, and shelf-life stability data, as these are complex biological considerations beyond typical device manufacturing.

What does "osteoinductive potential" mean for a bone graft, and how do manufacturers demonstrate it?

Osteoinductive potential refers to a graft's ability to stimulate mesenchymal stem cells to differentiate into osteoblasts, promoting new bone formation. Manufacturers typically demonstrate this through in vitro assays (e.g., alkaline phosphatase activity, gene expression analysis) and, critically, through in vivo animal models (e.g., nude mouse intramuscular implantation model) to show ectopic bone formation. This is a key differentiating factor, especially for DBM products.

What are common challenges in scaling production for novel synthetic bone graft geometries or composite materials?

Scaling novel synthetic grafts often introduces challenges in maintaining porosity consistency, achieving uniform material distribution in composite structures, and validating high-throughput sterilization methods without compromising material integrity. For complex geometries, tooling costs and manufacturing tolerances become critical, requiring manufacturers with advanced additive manufacturing or precision molding capabilities and extensive process validation expertise.

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