# Validating establishment of functional safety in skin interface  with deeply porous transcutaneous pylon for direct skeletal attachment of limb prostheses

> **NIH NIH R44** · POLY-ORTH INTERNATIONAL · 2022 · $731,608

## Abstract

Research efforts of the Poly-Orth International demonstrated feasibility of the novel
“Residuum-Integration Prosthetic Technology" to be used in direct skeletal attachment of
limb prosthetics. The technology includes a “Skin and Bone Integrated Pylon” (SBIP),
which connects the residuum with external limb prosthesis and can be especially
beneficial for patients who can not use traditional socket attachment of the prostheses.
 As histopathology analysis after the study with small and large animals has
demonstrated, the SBIP is integrated not only with the residual bone, but also with the
residuum’s skin minimizing the risk of infection and secondary trauma. The investigators
developed an optimal porous titanium matrix and design of the Skin and Bone Integrated
Pylon to maximize the ingrowth of bone and skin cells of the residuum to the SBIP
without compromising strength of the implanted device. The technological study on the
process of manufacturing of the composite porous structure enforced with a permeable
internal frame. Parameters of the SBIP’s specification are protected by the US Patent
#8257435.
 During the proposed translational pre-clinical study, the animal trials will be
conducted according to the FDA requirements to ensure smooth translation to the trials
in humans. It will include large animals (pigs) and the implantation period up to 22
months.

## Key facts

- **NIH application ID:** 10493303
- **Project number:** 5R44AR079960-02
- **Recipient organization:** POLY-ORTH INTERNATIONAL
- **Principal Investigator:** Mark Pitkin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $731,608
- **Award type:** 5
- **Project period:** 2021-09-24 → 2024-08-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10493303

## Citation

> US National Institutes of Health, RePORTER application 10493303, Validating establishment of functional safety in skin interface  with deeply porous transcutaneous pylon for direct skeletal attachment of limb prostheses (5R44AR079960-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10493303. Licensed CC0.

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