Why Sacrix chose HAP-TCP Resorbable Blast Media (RBM) Surface Texturing

by Dr. Kingsley R Chin MD MBA and Dr. Jason A Seale MBA

Sacrix Sacrofuse sacroiliac joint screw HAP-TCP RBM surface texturing from NANISX

Sacrix SacroFuse sacroiliac joint screws are surface textured coated with Resorbable Blast Media (RBM). RBM treatment roughens the implant surface without leaving the residual embedded blast particles or debris. By roughening the surface of the implant with RBM, SacroFuse achieves optimal osseointegration by increasing the success rate of Bone to Implant Contact (BIC) to allow bone integration around the implant while lessening the possibilities of post-surgery infections. RBM also provides increased retention strength.

The topography of RBM coating, down to the micrometer, affects the attachment and the growth of new bone cells, more rapidly and more stable. The RBM coating process consists of Hydroxyapatite (HAP) and TriCalcium phosphate (TCP) which are a highly resorbable and biocompatible to aid in bone formation. By using Calcium Phosphate as a blasting material, the process eliminates the need for using strong acids for the removal of blasting material remnants. The RBM surface technology results in excellent osseointegration with almost zero chance of abruption. Even if there is abrupted particles, they are fully biocompatible and thus will promote earlier bone in-growth and greater implant stability during the first critical weeks after screw placement across the sacroiliac joint.

HAP-TCP RBM coating

Top 3 Properties

  • Complies with standards: ASTM F1185 and F1088

  • Composition : Pure biphasic HA 85% / TCP 15% 

  • Particle size : 250-560µm, 160-250µm, 160-400µm ; 75-160µm ; 25-75µm


Top 3 Advantages

  • 100% biocompatible media forming an optimal surface morphology

  • Excellent solubility of the grains

  • Achievable roughness range for pure Ti and Ti alloy substrates: Ra > 2.0µm 

In summary, the RBM technology comprises of blasting and soft etching of the screw surface. The advantages of RBM are: 1) Biocompatible, easily-removed blasting shots; forming an optimal morphology. 2) Soft chemical treatment. RBM treatment ensures high surface cleanness with no risk of particle contamination or surface damage.

About Sacrix LLC
Sacrix LLC is a KICVentures Group portfolio company focused on revolutionary percutaneous fluoroscopic lateral-oblique transfixation technique for sacroiliac joint fusion for the treatment of sacroiliac dysfunction and sacroiliitis. Sacrix developed its patented Sacrofuse variable threaded implant to be inserted percutaneously and received FDA clearance in 2015. The Gen1 Sacrofuse implant was compared head-to-head with market leader SI bone (SIBN) and found to have a 400% increase in pull-out strength. Sacrix has trained over 200 interventional pain physicians, orthopedic surgeons and neurosurgeons to perform its revolutionary Sacrix SIJ fusion technique safely and effectively through a 1.5 cm incision minimally invasively in outpatient ambulatory surgery centers.
http://www.MySacrix.com

Reference:

RBM vs SLA comparison

About the authors

Dr. Kingsley R. Chin MBA is a board-certified Professor of Orthopedic Spine Surgery and honors graduate of Harvard Medical School, the Harvard Combined Orthopedic Residency Program and Harvard Business School for leadership. He did his spine fellowship with Dr. Henry H Bohlman. He was Chief of Spine Surgery at the University of Pennsylvania.

Dr. Jason A. Seale MBA is a medical doctor and entrepreneur. He is the clinical director at the LES Clinic.