OrthoFundamentals, LLC

OrthoFundamentals, LLC (now operating as Demetra Spine following acquisition by Demetra) designs and manufactures single-use surgical kits and 3D-printed implants for orthopedic and spinal surgery, with specific focus on SI (sacroiliac) joint fusion procedures in the outpatient surgery center market. The company's core platform combines pre-sterilized, single-use instrument trays with sterile-packed 3D-printed implants and RFID-enabled inventory management and automatic billing systems. Products are designed to eliminate contamination risk, instrument delays, and case cancellations caused by damaged packaging or missing instruments—key pain points in ambulatory surgery centers (ASCs). The Trellis SI Joint Fusion System represents the company's flagship offering. OrthoFundamentals targets orthopedic surgeons and ASC operators seeking cost-efficient, high-quality alternatives to traditional hospital-based care models. The company emphasizes value-based solutions and accessibility for outpatient settings, positioning itself against the complexity and cost of legacy MedTech commercial models. Manufacturing capabilities include 3D printing of implants and assembly of sterile procedural kits. The company holds regulatory clearance sufficient to market spinal fusion implants and surgical instruments in the US market, though specific 510(k) or FDA clearance details are not specified on the website.