ZETH

Our safe standard enables rapid and reliable bone repair

DBM
The putty version of the ZETH DBM (demineralized bone matrix) contains 80% demineralized human bone by volume and provides optimal characteristics for guided bone regeneration. The crush version of the ZETH DBM is a mix of 70% putty with 30% allograft cancellous crushed bone chips (1-6mm). This will allow a rigid and solid filling of the bone void. ZETH DBM is available in 1.0, 2.5, 5.0 and 10cc. The DBM is also available in flexible strips; these will become flexible after hydration. The DBM FLEX is available in three sizes: 15x15, 20x30 and 25x50mm.

The ZETH DBM products are processed by a four step production process by acidification of allograft bone chips. The whole production procedure will remove any cells and bacteria including DNA and RNA. This will ensure the ZETH DBM to be acellular. Our production is completed under environmentally controlled conditions. All steps are rigorously quality controlled.

KYERON DBM is a ready-to-use injectable and may be used in a variety of orthopaedic, reconstructive, neurosurgical, and periodontal tissue grafting procedures. KYERON DBM is a powerful bone graft material which provides superior handling characteristics.


BONE CHIPS
The ZETH human tissue is also available in cancellous and cortical-cancellous bone chips of different granules sizes and convenient volumes. The smallest granules size is 0.5-2mm and the largest is 4-10mm and it is available from 1cc to 60cc.

ZETH bone chips are completed under environmentally controlled conditions. All steps are rigorously quality controlled. ZETH bone chips may be used in a variety of orthopaedic, reconstructive, neurosurgical, and periodontal tissue grafting procedures.


AATB ACCREDITATION
KYERON and our tissue partners are accredited by the AATB and comply with the voluntary standards and guidelines developed by AATB. The source of human tissue for the ZETH products is USA, from an AATB approved bone bank.

In accordance with AATB and FDA requirements, KYERON and its recovery partners utilise extensive evaluation criteria to identify and exclude high risk donors. To ensure the safety of each allograft produced, all recovered tissue is first quarantined until donor eligibility has been established Donor eligibility is assessed using a comprehensive screening process that includes a complete medical and social history, physical examination, serological evaluation and microbiological testing.

Recovery of bone is conducted by highly trained procurement technicians in accordance with AATB standards. Technicians complete an examiniation to identify possible physical evidence of any high risk conditions and tissue recovery is performed within recommended time constraints. Aseptic techniques such as surgical skin prep and sterile instruments are utilised to ensure a high quality tissue.

A blood sample is collected from the donor and tested for infectious diseases by a CLIA-certified laboratory. Serological testing includes:
 - Antibody to Human Immunodeficiency Virus 1 & 2 (anti HIV 1 & 2)
 - Hepatitis B Surface ANitgen (HBsAg)
 - Hepatitis B Core IgG/IgM Antibody (HBcAb)
 - Antibody to Hepatitis C (anti-HCV)
 - Antibody to Human T-Cell Lymphotropic Virus Type I & II (anti-HLTV Type I & II)
 - Rapid Plasma Reagin or Serologic Test for Syphilis (STS by RPR)
 - Human Immunodeficiency Virus DNA using polymerase chain reaction (HIV NAT) using Transcription Mediated Amplification (TMA)

Swab cultures for microbiological testing are obtained either at the time of recovery or prior to processing. Cultures are incubated in two types of media at two temperatures for a minimum of seven days. Any aerobic or anaerobic bacteria detected are identified to the genus level.
Our freeze dried ZETH (DBM and ALLOGRAFTS) products are sterilised by gamma irradiation.

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