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 in the IFU that accompanies the product.
- 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.
