Cellular Bone Matrix

Cellular bone matrix (CBMs)

Signal Driven. Surgery Simplified.

CBMs like SygnaCel™ are engineered to work with the body’s natural bone healing process. By combining viable cells, including mesenchymal stem cells, with a demineralized bone fiber scaffold rich in native growth factors, CBMs provide both the cellular building blocks and the signals needed for bone growth and fusion. This dual mechanism supports robust bone regeneration across a range of grafting procedures.

SygnaCel™ CBM

Viable cells. Contains living cells that contribute directly to bone formation^†
Osteoinductive signal. Delivers the biologic cues needed to convert MSCs into osteoblasts^†
Rapid thaw and use. Prepares quickly in the OR to streamline surgical workflows
Versatile delivery. Integrates into both minimally invasive and open spinal fusion procedures¹
DMSO-free. Utilizes a non-toxic, biocompatible cryoprotectant that eliminates the need for decanting and rinsing required with traditional DMSO-based cryoprotectants.
Proven composition. Combines cryopreserved cortical cancellous bone matrix and demineralized bone fibers
Long use window. With 99% cell viability at 1 hour and 80% at 5 hours post-thaw, SygnaCel™ provides flexibility in case of surgical delays^‡
Enhanced safe processing. Proprietary Medtronic D-MIN™ and Xpel™ processing technologies enhance graft safety^†

Indications, Safety, and WarningsSygnaCel™ CBM important informationDescriptionSygnaCel™ cellular bone matrix is a formulation of human cryopreserved viable cortical cancellous bone matrix and demineralized bone fibers.Indications for useSygnaCel™ cellular bone matrix can be used as a bone graft in orthopedic or reconstructive procedures. Use SygnaCel™ cellular bone matrix in combination with autologous bone and/or bone marrow aspirate.SterilitySygnaCel™ cellular bone matrix is labeled as “aseptically processed, passes USP sterility tests.” It was aseptically processed and tested for sterility according to the current United States Pharmacopeia.ContraindicationsThe presence of infection at the implantation site is a contraindication for the use of this allograft.Warnings

SygnaCel™ CBM is a cellular bone matrix product containing viable cells.

Bone matrix products containing viable cells have been linked to, or associated with, two Mycobacterium tuberculosis (Mtb) outbreak events in the United States.

Some affected by these outbreaks have died.

Current donor screening, processing, and testing cannot fully eliminate the risk of disease transmission from bone matrix products containing viable cells.

Potential adverse eventsDonor screening methods are limited. Therefore, certain diseases and infectious agents may not be detected and/or eliminated during processing. The following complications of tissue transplantation may occur:

Loss of function or integrity of transplanted tissue due to resorption, fragmentation, or disintegration including associated loss of continuity, or displacement, and/or fracture at treatment site

Non-union (or pseudarthrosis), delayed union, and/or mal-union

Immune rejection of transplanted grafts or infection

Transmission or causation of known diseases as well as diseases of unknown etiology and characteristics

Transmission of known infectious agents including HIV, hepatitis B, hepatitis C, and bacteria (e.g., syphilis, Mycobacterium tuberculosis)

Death

CautionThis allograft may contain trace amounts of processing agents. Caution should be exercised if the patient is allergic to any of these agents.PrecautionsDespite extensive donor selection and qualification processes, transmission of disease is still possible. Bacterial or fungal infection may also occur.Donor screening and testingThe donor was screened in accordance with FDA regulations and standards established by the AATB. The donor was also screened for HIV, Hepatitis, and CJD/vCJD risk factors. Donor blood was tested for communicable disease by a laboratory registered with the FDA using FDA approved, licensed, or cleared tests. Results of tests were negative or non-reactive. Laboratory-developed Mtb NAT (nucleic acid amplification testing) and culture testing for Mtb was also performed. Note that there are currently no FDA approved tests for Mtb detection in cadaveric tissues. Testing for Mtb may not detect inactive (latent) mycobacteria.For a complete list of indications, safety, and warnings, please visit manuals.medtronic.com

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† Data on file. Animal testing is not necessarily indicative of human clinical outcomes.

‡ Average based on internal testing

Cellular bone matrix (CBM)