Cellentra® Advanced Allograft

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The Complete Bone Remodeling Triad

Cellentra Advanced Allograft is a human tissue allograft consisting of cryopreserved cancellous bone combined with demineralized cortical bone matrix. This unique combination provides all three components of the bone remodeling triad, osteoconductivity, osteoinductivity and osteogenicity.

Excellent Safety Profile

  • Cellentra Advanced Allograft test samples were shown to be immuno-protective and immuno-suppressive
  • Processed via stringent donor screening, testing and sterility procedures

Optimal Handling

  • Graft composition designed to provide superior handling
  • Consistent graft-packing capabilities
  • Syringe delivery may facilitate controlled graft placement

Device Description

Cellentra is a human tissue allograft consisting of cryopreserved cancellous bone combined with partially demineralized cortical bone matrix. 

 

Indications

Cellentra is an allogeneic bone graft substitute containing viable donor cells intended for homologous use in the repair, replacement, reconstruction, or supplementation of the recipient’s tissue in musculoskeletal defects. These defects may be surgically created defects or defects created from traumatic injury to bone.

 

Contraindications

  • Sensitivity or allergies to any of the processing agents listed under the Processing section of this document 
  • Use in immune compromised patients 
  • Use as a standalone in load-bearing applications

 

Warnings and Precautions

  • As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted. This risk is greatly reduced by using processing treatments shown to be capable of reducing this risk as well as the use of strict donor screening criteria and laboratory testing. 
  • Single patient, single use only. Re-use may result in tissue contamination, patient infection, and/or failure to perform as intended. 
  • Do not sterilize. 
  • Do not use if the package integrity is damaged or compromised. Return all packages with flaws to the supplier. 
  • Do not use if expiration date has been exceeded. 
  • Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or clinician. Do not use if tissue has not been stored according to the recommended storage instructions. 
  • Do not use if the labels or identifying barcodes are severely damaged, not legible, or missing. 
  • Prior to clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the tissue. 
  • Although the osteoconductive, osteoinductive and osteogenic characteristics of the native bone have been retained, the bench testing results may not be indicative of clinical outcome. 

 

Possible Adverse Effects

Inherent uncertainty exists in medical and social histories and lab testing which may not detect known or unknown pathogens. Therefore the following complications may occur with tissue transplantation: 

  • Transmission of diseases of unknown etiology; 
  • Transmission of known infectious agents including, but not limited to viruses, bacteria and fungi; 
  • Immune rejection of implanted allograft; or 
  • Loss of function and/or integrity of implanted allograft due to resorption, fragmentation, and/or disintegration 

The physician is responsible for promptly reporting any adverse reaction that may be potentially attributable to the allograft. Comments regarding this tissue can be directed to: Attn: Quality Assurance Biomet Spine 310 Interlocken Parkway Suite 120, Broomfield CO 80021 (800) 447-3625

* Data on File. 

** In vitro cellular and pre-clinical studies may not be indicative of human clinical outcomes.

Legal Manufacturer:

Zimmer Biomet Spine, Inc.
310 Interlocken Parkway #120
Broomfield, CO 80021


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This material is intended for health care professionals.  Distribution to any other recipient is prohibited.
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website.