GEM Allograft Bone Matrices

Lynch Biologics is proud to partner with a world-leading tissue processor to create a unique and differentiated allograft product offering that’s 100% GUARANTEED OSTEOINDUCTIVE – GEM ALLOGRAFT!

We have used our extensive orthopedic experience to find regenerative products that we believe best meet, and exceed, the needs of the surgical dentist.  Our proprietary process delivers greater surface area to facilitate revascularization and support in-growth of new bone.

Why is GEM ALLOGRAFT unique?

  • Every lot. tested and proven osteoinductive, in contrast to most other bone allograft
  • Our line of osteoinductive fibers and putties are extensively tested utilizing an animal implant model and in-vitro AP model to confirm inductive potential
  • Higher surface area generated by the elongated particulate shapes, not the “rocks” produced by cheaper (and more expensive) alternatives
  • Higher surface area facilitates greater stimulation of revascularization and in-growth of new bone
  • All products achieve sterility assurance levels (SAL) of 10-6, and are processed in accordance with AATB Standards and FDA regulations

Lynch Biologics’ GEM Allografts are PROCESSed using:

  • All products are processed aseptically using proprietary BioRinse™ decontamination technology, and in accordance with AATB Standards and FDA federal regulations.
  • BioRinse™ is validated decontamination process that uses proprietary rinsing agents in multiple combinations designed to kill pathogenic microorganisms, vegetative bacteria and spores. These steps include the removal of debris, blood, bone marrow and lipids, and components associated with disease transmission.
  • BioRinse™ in combination with a final low-dose sterilization step under low-temperatures ensures a 10-6medical device sterility assurance level (SAL) in accordance with a Sterile “R” claim, while preserving the osteoinductive potential of the graft.

Allograft tissue processing partner facts

  • All DBM products verified for Osteoinductivity; Every lot, Post-Sterilization. Both In-Vivo & In-Vitro testing performed
  • All products have medical device Sterility Assurance Level (SAL) of 10-6
  • United States (U.S.) Food & Drug Administration (FDA) Registered
  • American Association of Tissue Banks (AATB) Accredited
  • Company only processes donated human tissue
  • Donors come from U.S. and Canada Registered Recovery Agencies
  • To date, no company product has been recalled or withdrawn

GEM ALLOGRAFT BONE MATRICES

MINERALIZED Bone Fibers

Proprietary processing delivers elongated particulate, creating greater surface area to support revascularization and support in-growth of new bone compared to the mineralized “rocks” produced by other cheaper, and more expensive, allograft tissue processors.
  • GEM Cortical FDBA: Mineralized Cortical Particulate allograft provides all the benefits of cortical bone, including greater amounts of BMPs compared to cancellous bone, and is a slower resorbing material, ideal for space maintenance and increased mineralized tissue for longer times
  • GEM Cancellous FDBA: Mineralized Cancellous Particulate provides increased surface area and porosity which allows for capillary ingrowth, which in turn promotes formation of osteoblasts for new bone growth
  • GEM Cortical Cancellous FDBA: Mineralized Cortical/Cancellous Particulate (approximately 60/40 mix) blends the advantages of cortical and cancellous FDBA.

 

  • Osteoconductive
  • Sterile – Sterility Assurance Level (SAL) or10-6 Two-year shelf life
  • 100% allograft bone – no additional carrier
  • Room temperature storage
Particulate Cortical Grafts – Small Particle 0.25 – 1.0mm

  • .25cc | LBFDBASP025
  • .5cc | LBFDBASP05
  • 1.0cc | LBFDBASP1
  • 2.0cc | LBFDBASP2

Particulate Cancellous Grafts – Small Particle 0.25 – 1.0mm

  • .25cc | LBCFDBA025
  • .5cc | LBCFDBA05
  • 1.0cc | LBCFDBA1
  • 2.0cc | LBCFDBA2

Particulate Cortical Cancellous Grafts – Small Particle 0.25 – 1.0mm

  • .25cc | LBCCFDBA025
  • .5cc | LBCCFDBA05
  • 1.0cc | LBCCFDBA1
  • 2.0cc | LBCCFDBA2
Mineralized Cancellous Particulate
Mineralized Cortical/Cancellous Particulate

DEMINERALIZED BONE matrices – VERIFIED OSTEOINDUCTIVE

Each lot of Lynch Biologics GEM Demineralized Bone Matrix that is incorporated in the Fibers and Putties below, has been histologically proven to generate all five (5) elements of bone formation including new bone, bone marrow, osteocytes, chondrocytes and cartilage in the athymic rat post-implantation model at 28 days.  In vivo testing is performed by an independent laboratory on every lot of GEM DEMINERALIZED BONE MATRIX product POST STERILIZATION to ensure VERIFIED OSTEOINDUCTION.

These products have been processed to preserve native BMP’s and provide for an unparalleled osteoactive graft.

Moldable ALLOMIMETIC Putty

MODLABLE ALLOMIMETIC PUTTY is THE solution for those indications where migration of a graft is not acceptable, and you require a verified osteoinductive material. The proprietary combination of our particulates and fibers with NO inert carrier to block capillary ingrowth and cellular migration. Migration resistant while sustaining the desired hydrating constituent.

MODLABLE ALLOMIMETIC PUTTY is verified for osteoinductivity, each lot, post-sterilization prior to release for distribution. In-vivo test results have histologically demonstrated the presence of all 5 bone-forming elements (chondrocytes, osteocytes, bone marrow, cartilage, and new bone).

MODLABLE ALLOMIMETIC PUTTY does not contain any extrinsic carriers and is made from 100% human bone.

MODLABLE ALLOMIMETIC PUTTY is provided sterile with a sterility assurance level (SAL) 10-6. The product should be stored in room temperatures (59-86° F or 15-30° C) and has a shelf-life of up to 2 years from the date of packaging.

  • Osteoconductive and Osteoinductive
  • 100% allograft bone – no additional carrier
  • Stays where you put it;  Resists compression from the flap, and displacement from irrigation
  • Sterile – Sterility Assurance Level (SAL) or 10-6
  • Two-year shelf life
  • Room temperature storage
  • 1.0 cc | LBDBMM1

DEMINERALIZED CORTICAL Bone FIBERS

DEMINERALIZED CORTICAL BONE FIBERS have been processed utilizing a proprietary process and have been histologically proven to generate all five (5) elements of bone formation including new bone, bone marrow, osteocytes, chondrocytes and cartilage in the athymic rat post-implantation model at 28 days.  In-vivo testing is performed by an independent laboratory on every lot of GEM DEMINERALIZED BONE MATRIX product POST STERILIZATION.

DEMINERALIZED CORTICAL BONE FIBERS may be hydrated with saline, sterile water, blood, or protein containing solutions in accordance with clinicians well-informed medical judgment. GEM DEMINERALIZED CORTICAL FIBERS do not contain extrinsic carriers, and are derived entirely from 100% human allograft bone.  GEM DEMINERALIZED CORTICAL FIBERS are provided in a ready-to-use mixing jar.

DEMINERALIZED CORTICAL BONE FIBERS are provided sterile with a Sterility Assurance Level (SAL) 10-6.  The product should be stored at ambient temperatures and has a shelf life of five-years from date of packaging.

  • Osteoinductive and osteoconductive
  • 100% woven demineralized cortical fibers
  • Sterile – Sterility Assurance Level (SAL) or 10-6
  • Five year shelf life
  • BioRinse™ process removes cellular components associated with inflammatory response while leaving matrix intact.
  • Ambient storage temperatures (dental sizes)
  • 1.0 cc | LBDCF1

Demineralized Flowable Fibers in Syringe

DEMINERALIZED FLOWABLE FIBERS IN SYRINGE is derived of 100% allograft bone and processed using a proprietary demineralization process.

DEMINERALIZED FLOWABLE FIBERS IN SYRINGE has histologically demonstrated, post sterilization, to exhibit all five (5) elements of bone formation.

DEMINERALIZED FLOWABLE FIBERS IN SYRINGE does not contain any extrinsic or inert carriers.

DEMINERALIZED FLOWABLE FIBERS IN SYRINGE is provided in a ready to use syringe.

GEM DBM Putty is provided sterile with a medical device Sterility Assurance Level (SAL) 10-6.  The product should be stored at room temperature and has a shelf life of two-years from date of packaging.
  • Osteoconductive and Osteoinductive
  • 100% allograft bone – no additional carrier
  • Stays where you put it;  Resists compression from the flap, and displacement from irrigation
  • Sterile – Sterility Assurance Level (SAL) or 10-6
  • Two-year shelf life
  • Room temperature storage
  • Available in delivery syringe
  • 0.5 cc | LBDCM05
  • 1.0 cc | LBDBM1