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Description and Intended Use
Bio-Reign® 3D is a resorbable bone void filler intended to fill bony voids or gaps of the extremities and pelvis. It is radiolucent and composed of hyper crosslinked carbohydrate polymer with a total porosity of greater than 75%. Pores are mainly distributed within a range of 100-500 μm. When placed in direct contact with patient’s bone, Bio-Reign® 3D supports and guides the ingrowth of new bone across the graft site and is resorbed as the healing process occurs. The consistency of Bio-Reign® 3D allows the surgeon to easily manipulate and maximize its direct contact with viable host bone.

Bio-Reign® 3D is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) with the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone.

Clinically Relevant Features:

Built from a hyper-crosslinked carbohydrate polymer designed to mimic key structural aspects of the native extracellular environment2
Provides a highly porous scaffold that supports cellular infiltration1,2
Radiolucent, enabling visualization of new bone formation2
Demonstrated biocompatibility in both preclinical and clinical evaluations1,2

Clinical Evidence

Read our pre-clinical and clinical evidence to learn more about the clinical data supporting our portfolio.
Hyper-Crosslinked Carbohydrate Polymer for Repair of Critical-Sized Bone Defects
In Vivo Performance of a Novel Hyper-Crosslinked Carbohydrate Polymer Bone Graft Substitute for Spinal Fusion
Bridging and Repair of First Metatarsal Fracture with Chronic Pseudoarthrosis Following Multiple Surgical Interventions Using a Minimally Invasive Approach

Three Configurations

Read our pre-clinical and clinical evidence to learn more about the clinical data supporting our portfolio.
Granules
Available in 5 cc, 10 cc, 20 cc, and 30 cc volumes
Sheets
Available in 25-75 mm length and
3 mm thickness
Blocks
Available in 6-14 mm width sizes

Ordering Information

  • Code Description
  • BR-G5 Bio-Reign 3D Bioactive Matrix Granules Small
  • BR-G10 Bio-Reign 3D Bioactive Matrix Granules Medium
  • BR-s25x50x3Bio-Reign 3D Bioactive Matrix Sheet 25mm x 50mm x 3mm
  • GSB-14 BioReign 3D Bioactive Matrix Block 14x10x14

REFERENCES

1. Koleva PM, Keefer JH, Ayala AM, Lorenzo I, Han CE, Pham K, Ralston SE, Kim KD, Lee CC. Hyper-Crosslinked Carbohydrate Polymer for Repair of Critical-Sized Bone Defects. BioResearch Open Access. 2019;8(1):111-120. doi:10.1089/biores.2019.0021
2. Kim KD, Batchelder CA, Koleva P, Ghaffari-Rafi A, Karnati T, Goodrich D, Castillo J, Lee C. In Vivo Performance of a Novel Hyper-Crosslinked Carbohydrate Polymer Bone Graft Substitute for Spinal Fusion. Bioengineering. 2025;12(3):243. doi:10.3390/bioengineering12030243.