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Product Information

The Geistlich® Allogenic Bonegraft CSP family offers a complete range of allograft solutions designed to meet everyday regenerative procedure needs.

Each graft is processed using the Cancelle SP® Sterilization Process, a proprietary, validated method that removes debris and inactivates and/or removes a panel of microorganisms while maintaining biocompatibility.1

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About Geistlich® Allogenic BoneGraft CSP

  • Choice of five configurations for cortical, cancellous, and blended particulates
  • Convenient volume options ranging from 0.25 cc to 2.0 cc (varies by type)
  • Particle size range: 250–1,000 microns for optimal handling and packing
  • 70% mineralized cortical / 30% DBM mix for clinicians seeking both osteoconductive and osteoinductive potential
  • Each lot of implants containing DBM is lot release tested for BMP-2.1 BMPs are recognized as a marker of osteoinductive potential.*


* Having the ability to induce bone growth.

Geistlich® Allogenic BoneGraft CSP Configurations

Mineralized Cortical/
Cancellous Natural Blend

Mineralized
Cancellous

Mineralized Cortical

70% Mineralized Cortical/
30% DBM

Cortical Demineralized Bone Matrix

Quality Starts with the Donor

Donor Assessment

Each donor is evaluated for diseases that could impact tissue quality.

Record Review

A comprehensive review of all relevant donor records is conducted prior to tissue release.

Risk Assessment Interview

Independent licensed recovery agencies interview donor’s next of kin to assess donor risk factors.

Physical Assessment

Recovery agency performs a physical examination of the donor to identify any signs of infection or conditions that may adversely affect tissue.

Cancelle SP® Sterilization Process

The Cancelle SP® Sterilization Process is a proprietary process that sterilizes demineralized bone matrix (DBM) and cortical cancellous chips (CCC). This process is validated to inactivate and/or remove a panel of microorganisms without the use of antibiotics.1

  • A combination of treatments and washes removes debris from the graft material.
  • Cleansing rinses eliminate residual chemicals to ensure biocompatibility.
  • Low-temperature, low-dose gamma irradiation helps preserve the utility and biological properties of the graft.

Geistlich® Allogenic
BoneGraft CSP

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Frequently Asked Questions

How do tissue banks differ?

Tissue banks are required to register with the U.S. Food and Drug Administration (FDA) and are inspected regularly for compliance to federal regulations. The American Association of Tissue Banks (AATB) is a voluntary industry led organization that provides additional recommendations on standards that affect allograft safety and efficacy. Beyond the FDA and the AATB recommendations, each tissue bank has its own methods for donor screening, processing and sterilization which play a role in the safety of the grafts provided for clinical use. It is important to ask questions regarding a tissue bank’s donor screening criteria, processing methods, testing, and studies to ensure the allografts used meet the clinical need for safety and efficacy.

It is important to note that RTI Surgical, Inc. d/b/a Evergen is accredited by the AATB and  ISO 13485:2016 certified.

What are the advantages of demineralized bone versus mineralized bone? Where would you use a demineralized allograft versus a mineralized allograft in clinical procedures?

The demineralized bone has been treated to remove the calcium and expose the inherent growth factors in bone. Mineralized allograft remains longer, providing a matrix for new bone formation to occur. The main clinical use for demineralized allograft is guided tissue regeneration.2

What testing is performed to confirm the osteoinductive potential of implants containing DBM?

Each lot of allograft containing DBM is lot release tested for BMP-23. BMPs are recognized as a marker of osteoinductive potential.

Are allografts visible on radiographs?

Mineralized allografts are visible on radiographs due to the mineral content in the materials. Demineralized bone, however, is not visible on radiographs, until the bone is reincorporated as a part of the healing process and becomes mineralized.

What is the resorption profile of a demineralized versus a mineralized allograft?

Demineralized bone will have a faster absorption profile compared to mineralized grafts. Mineralized bone grafts will integrate between 6-12 months depending on particle size, whereas demineralized bone grafts will integrate within 18-20 weeks.4 Traditionally a blend of mineralized and demineralized grafts is used to balance the healing process and incorporation times.

Are cancellous and cortical bone both osteoconductive?

Yes, both mineralized and demineralized cancellous and cortical bone can provide osteoconduction. Osteoconduction by definition means that bone grows on a surface. An osteoconductive surface is a matrix that permits bone growth on its surface or within its pore structure.5 Given that cortical and cancellous bone can serve as a scaffold for ingrowth of new bone, they both can be considered osteoconductive.6

What is the FDA regulatory status for Geistlich® Allogenic Bonegraft CSP?

Geistlich® Allogenic Bonegraft CSP is regulated as a human cell/tissue product (HCT/P) under 21 CFR Part 1271.10. FDA registration listing can be found on the company website or can be provided upon request.

What is the Cancelle SP® Sterilization Process?

The Cancelle SP Sterilization Process is a proprietary process that sterilizes demineralized bone matrix (DBM) and cortical cancellous chips (CCC). Through a combination of oxidative treatments and acid or alcohol washes, debris is removed. Cleansing rinses remove residual chemicals, maintaining biocompatibility. Low-temperature, low-dose gamma irradiation preserves the utility of the graft. For the Geistlich Allogenic Bonegraft CSP, the irradiation dose is applied terminally to achieve an SAL of 10-6.7

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  1. Data on file with RTI Surgical, Inc.
  2. Gruskin, E. et al. Demineralized bone matrix in bone repair: History and use. Advanced Drug Delivery Reviews 64 (2012) 1063-1077.
  3. Data on file with RTI Surgical, Inc.
  4. Wood and Mealey, Histologic comparison of healing after tooth extraction with ridge preservation using mineralized versus demineralized freeze-dried bone allograft, J Periodontol, March 2012.
  5. Albrektsson T, Johansson C. Osteoinduction, osteoconduction and osseointegration. Eur Spine J. 2001;10(Suppl 2):S96–S101. doi:10.1007/s005860100282
  6. Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics. Organogenesis. 2012;8(4):114–124. doi:10.4161/org.23306. 
  7. Cancelle SP® is a registered trademark of RTI Surgical, Inc. d/b/a Evergen.

Disclaimer: Lab data may not be representative of effects or performance in humans.