Bio-Integrative OSSIOfiber® Compression Screw and Sterile, Disposable Instrumentation

Superior Fixation meets Better
Bone Healing. The Patient Experience is
Yours to Transform.

Our Compression Screws deliver superior performance to conventional metal screws1,2 and gradually integrate fully into bone, for a true return to full strength and a total healing that other implants simply can’t provide. 

Bio-Integrative OSSIOfiber® Compression Screws

  • Comprised of OSSIOfiber® Intelligent Bone Regeneration Technology
  • Superior to conventional metal compression screws in compression and pull-out resistance1,2, and equivalent in shear and flexural stability in an osteotomy construct3. Gradual load sharing minimizes stress risers and promotes return to function
  • Up to 5X increased surface area available for bone integration may contribute to a more stable construct4
  • Artifact free on CT, X-Ray. MRI safe

Choose the size and orientation that best fits your patients’ needs:

  • 4.0mm diameter with 26 – 60mm lengths in 2mm increments

  1. In Vitro Initial Compression Strength Test. Data on File at OSSIO.
  2. In Vitro Pull-Out Strength Test of 3.5x26mm OSSIOfiber Compression Screws. Data on File at OSSIO.
  3. In Vitro Test in a Simulated Medial Malleolar Construct. Data on File at OSSIO.
  4. In Vitro Data on File at OSSIO.
  5. Data on File at OSSIO.
  6. Pre-clinical animal studies (in-bone implantation of OSSIOfiber and PLDLA control in rabbit femurs). Data on File at OSSIO.

Performance Data

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Pullout_150x150@2x
Equivalent_150x150@2x (1)

Sterile, Single-Use Instrumentation System

  • Pre-sterilized, single-use packaging with convenient disposable instruments to reduce unnecessary exposure to pathogens
  • AO Quick Connect Handle
  • Cannulated Depth Gauge / Countersink
  • Drill Guide
  • Cannulated Drill Bit, Size 3.2mm
  • Cannulated Tap
  • Hex Driver
  • Three 1.1mm K-Wires

Indications for Use

OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization. Choose strong and bio-integrative OSSIOfiber® Compression Screws in lieu of standalone conventional, metal compression screws.

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For Product Inquiries, Customer Service & Ordering Information Contact Us At:

(833) 781-7373  |  info@ossio.io

Surgical Technique for the OSSIOfiber® Compression Screw

Superior Fixation with Familiar, Reproducible Technique

Achieve Natural Bone Healing without Tradeoffs on Performance or Trusted Technique

  • Pre-sterilized, single-use packaging with convenient disposable instruments to reduce unnecessary exposure to pathogens
  • Streamlined, cannulated instrumentation

     *For illustration purposes only

The Science Behind OSSIOfiber® Bio-Integrative Technology

A True Breakthrough in Orthopedic Fixation

As a first-of-its-kind implant material, OSSIOfiber® is stronger than cortical bone and leaves nothing permanent behind. It leverages the individual integration mechanism of both material components and internal micro-architecture to achieve the optimal environment for bone healing.

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Bio-Integrative OSSIOfiber® Compression Screw Case Study

Don’t Just Fix It with Conventional Metal – Heal It Naturally with Bio-Integrative OSSIOfiber®

In a full load-bearing osteotomy fixation ovine model, OSSIOfiber Compression Screws successfully demonstrated performance and mechanical integrity through 6 months. OSSIOfiber® material technology has similar radiodensity to cortical bone, is artifact-free on X-ray/CT and MRI safe.

  • At 2 weeks post-operative, all subjects returned to normal gait and function with X-rays demonstrating stable fixation and good anatomical alignment

 

  • At 3 months post-operative, all animals demonstrated bony fusion with 100% bone bridging across osteotomy sites, well maintained reduction of the osteotomy and no evidence of implant migration

 

  • At 6 months post-operative, all animals showed optimal biocompatibility, maintained structural integrity of the implants and excellent bio-integration with early mesenchymal cellular investment into the implant

Micro-CT Imaging at 6 months post-operative demonstrating accurate reduction and excellent bone healing and fusion.

Frequently Asked Questions (FAQ)

What procedures are the OSSIOfiber®Compression Screws indicated for?

The OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.

Choose strong and bio-integrative OSSIOfiber® Compression Screws in lieu of standalone conventional, metal compression screws.

Is the OSSIOfiber® Compression Screw covered under existing reimbursement?

Yes, the OSSIOfiber® Compression Screw is covered under existing reimbursement codes in the US for common orthopedic procedures. Please contact OSSIO for more information.

What makes OSSIOfiber® different from a bio-resorbable implant?

OSSIOfiber® is the first and only Bio-Integrative Implant Technology. It is 5x stronger than conventional bioresorbables and uniquely contributes to early bone attachment and subsequent bone integration. Findings from a 2-year preclinical study comparing OSSIOfiber® to bioresorbables showed that unlike bioresorbables, OSSIOfiber® integrates in a gradual and predictable way, with no adverse inflammation observed. To learn more about our research, please fill out the form below and an OSSIO team member will be in touch.

How long does resorption take?

OSSIOfiber® fully incorporates with the surrounding anatomy in 78-104 weeks, as proven in pre-clinical studies. Bone attachment begins in as little as 2 weeks and continues in a gradual, predictable profile. For more information, please fill out the form below and an OSSIO team member will be in touch.

Where is OSSIOfiber® available?

OSSIOfiber® is currently commercially available in the US. If you are interested in using OSSIOfiber®, please fill out the form below and a team member will be in touch.

Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique.

Additional Resources

OSSIOfiber™ Hammertoe Fixation Case Study

Digital
Brochure

OSSIOfiber™ Technology White Paper

Contact Us

Get in touch with a sales representative or ask us a question.

Address

Commercial Headquarters

OSSIO Inc
300 TradeCenter, Suite 3690
Woburn, MA. 01801

Science & Technology Center

OSSIO Ltd.
8 HaTochen Street.
Caesarea, Israel 3079861

Customer Service

For product inquiries or purchasing questions contact 833-781-7373 or email info@ossio.io