Description and Intended Use
Bio-Reign Luxe® is comprised of porous ceramic granules made of bi-phasic calcium phosphate ceramic, 80% hydroxyapatite Ca5 (PO4)3(OH) and 20% β-tricalcium phosphate Ca3(PO4)2 with 0.8% silicate SiO2.
Bio-Reign Luxe® is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis, with use of supplemental internal fixations where required. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bio-Reign Luxe® resorbs and is replaced with bone during the healing process.
Bio-Reign Luxe® Consists of:
Silica-induced Bi-phase Calcium Phosphate Ceramic Granules
80%
Hydroxyapatite (HA)
20%
Beta-Tricalcium Phosphate (β-TCP)
Bio-Reign Luxe® 1cc and 10cc are supplied in a sterile applicator containing porous ceramic granules suspended in an aqueous polymer carrier gel.
Bio-Reign Luxe® 3cc and 5cc are supplied in a sterile applicator containing porous ceramic granules suspended in a dehydrated version of an aqueous polymer carrier gel.
The delivery applicator is to facilitate the delivery directly into the defect site, or the user may dispense into the hand for manual manipulation.
Ordering Information
| Code | Size | Description |
|---|---|---|
| BRL-1 | 1.0cc | 1.0cc syringe pre-hydrated |
| BRL-3 | 3.0cc | 3.0cc syringe |
| BRL-5 | 5.0cc | 5.0cc syringe |
| BRL-10 | 10.0cc | 10.0cc syringe pre-hydrated |