Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 17751 - bone matrix implant, synthetic - non structural bioactive synthetic bone graft substitute that is resorbable composed of biphasic calcium phosphate microgranules( 60%hydroxyapatite/40% beta -tricalcium phosphate) and a viscoelastic polymer. it acts as a bone void filler and has a micro- macroporous structure with 70% porosity that acts as scaffold for new bone tissue growth in addition to release of ions into target area. supplied in a malleable form to perfectly fit with bone defect shape loaded in a syringe applicator. in?oss? is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. when packed into a bony site, in?oss? gradually resorbs and is replaced with bone during the healing process.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 44795 - bender, orthopaedic - a reusable surgical instrument used to bend medical devices, typically those for implantation to the appropriate anatomical fit.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 32885 - wire cutter - a device used to cut wire or pins or similar during surgical procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 35048 - elevator, orthopaedic - a surgical instrument used during orthopaedic surgery to lift, position, or pry up bone, other anatomic structures or surgical material.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 44378 - bone distraction forceps - a hand-held manual surgical instrument with sturdy handles and blade or paddle like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 13730 - sterilization container - a receptacle designed to hold unwrapped surgical instruments, typically devices such as surgical powered drills and saws along with their hoses, during sterilization and for their subsequent storage. the container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. it may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 16966 - graft, bone, synthetic - reprobone? is a mixture having a nominal composition of 60% hydroxyapatite and 40% ?-tricalcium phosphate. reprobone? is a safe and fully biocompatible material which is designed to act as an osteoconductive scaffold to support the ingrowth and fusion of adjacent viable bone when placed in an osseous environment. reprobone? will later resorb and be replaced by natural bone. reprobone? is a synthetic osteoconductive bone substitute in block and granular form that is intended to be used as a scaffold to support the ingrowth of adjacent viable bone in defects that are not intrinsic to the stability of the bone structure. these defects may be located in the extremities, spine, pelvis or cranium, and reprobone? may also be used in the same manner during hip surgery and hip revision surgery. the blocks or granules may be gently pressed into the defect by hand or shaped to more accurately fit the defect, and may also be soaked with bone marrow aspirate prior to implantation. repro-bone? will act as a temporary scaffold and is not intended to provide structural support during the healing process. the implant is biocompatible, radio-opaque and will eventually resorb in a controlled way

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 16966 - graft, bone, synthetic - reprobone novo is a mixture of nanocrystalline hydroxyapatite in water. it is biocompatible designed to act as an osteoconductive medium to support ingrowth and fusion of the adjacent viable bone when placed in an osseous environment. will fully resorb and be replaced by natural bone due to its nanocystalline structure. intended to be used for filling and supporting the ingrowth of adjacent viable bone in bone defects that are not intrinsic to the stability of the bone structure. these defects may be located in the extremities, pelvis, spine or dental or peridontal or mandibular areas; and used for filling of bone defects in the case of fractures, resection or benign tumours or cysts, for filling cages and for filling autograft harvest sites; defects of the alveoloar ridge or wall inclusive extraction sockets and for filling periodontal defects. intended to act as a temporary scaffold and will remain as a soft paste and is not intended to provide structural support during hte healing process. biocompatible, radiopaque and will resorb in a controlled way.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 37272 - fixation device, internal, spine, construct - a spinal fixation system that consists of various components such as rods/hooks/screws/connectors and wires that are used collectively to stabilize, support and/or correct alignment of the spine. the combination of these components is intended for the treatment of various spinal instabilities, pathologies and/or deformities. these components may be made of stainless steel, titanium, cobalt chrome or other materials.

Australia - English - Department of Health (Therapeutic Goods Administration)

prism surgical designs pty ltd - 46653 - spinal fixation plate, non-biodegradable - this device is attached to the anterior/posterior spine with screws for spinal immobilization. it is typically used to provide immobilization and stabilization of the spinal segments in the treatment of various spinal instabilities or deformities during cervical, thoracic, lumbar and sacral fixation procedures.