# R-FIX (Rib-FIXation) Spinal Growth System for Early-onset Spinal Deformity

> **NIH NIH R44** · APEX ORTHOPAEDIC TECHNOLOGIES LLC · 2024 · $1,238,710

## Abstract

Project Summary
Early-onset spinal deformity is a subset of pediatric spinal deformity that begins before the age of 10 years.
Unlike adolescent idiopathic scoliosis, it is a life-threatening disease, which makes early intervention crucial.
Surgical intervention must accommodate the growth of the developing spine, making this one of the most
challenging orthopedic conditions to treat. Current intra-spinal based treatments, such as growing rods with
pedicle screw fixation, have high complication rates and limited effectiveness. The R-FIX (Rib-FIXation) Spinal
Growth System is an alternative extra-spinal technique that uses rib-based fixation for correcting early-onset
spinal deformity. This extra-spinal rib fixation is a paradigm shift from seeking correction of the spine to
emphasizing correction of thorax malalignment. The R-FIX System originated from a bioengineering lab (one of
the applicants' labs) at Clemson University and has been further developed by Apex Orthopaedic Technologies.
The R-FIX Spinal Growth System has been granted breakthrough device designation by the FDA. The objective
of this SBIR Phase II award is threefold: 1) complete the final design, manufacturing, and quality control
processes for the new R-FIX System components, 2) obtain the necessary biomechanical, biocompatibility, and
sterility data resulting in successful 510(k) clearance of the R-FIX System, and 3) demonstrate the safety and
efficacy of new R-FIX uni-axial rib hook and rib band designs in an animal model. This research will be conducted
over 24 months and the data obtained from this grant proposal will result in a 510(k) application for FDA
clearance and follow-up NIAMS pediatric medical device initiative clinical trial application. Major milestones to
be achieved with this grant include 1) validation of new implantable R-FIX components with surgeon feedback,
2) completion of benchtop performance testing and FDA 510(k) submission, and 3) assessment of the safety
and efficacy of new R-FIX components compared to pedicle screws in a pediatric hyperkyphosis porcine animal
model.

## Key facts

- **NIH application ID:** 11013594
- **Project number:** 2R44AR080507-02
- **Recipient organization:** APEX ORTHOPAEDIC TECHNOLOGIES LLC
- **Principal Investigator:** Daniel James Bonthius
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,238,710
- **Award type:** 2
- **Project period:** 2022-09-20 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11013594

## Citation

> US National Institutes of Health, RePORTER application 11013594, R-FIX (Rib-FIXation) Spinal Growth System for Early-onset Spinal Deformity (2R44AR080507-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11013594. Licensed CC0.

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