MEDICAL DEVICE MANUFACTURERS - TRAUMA

Your partner in non-metal fracture fixation

Learn how Invibio can support you from concept to commercialization for next-generation trauma devices
Learn more

Why partner with Invibio

Invibio is here to help you every step of the way through the design, regulatory, manufacturing and commercialization process, providing unmatched opportunities to bring next generation devices to market quickly. We welcome the opportunity to partner with you on your next implantable fracture fixation device.

Contact an expert

Meeting the future needs of medical device companies, surgeons and patients

Invibio is committed to developing solutions can bring significant advantages for patients and surgeons. We are more than a biomaterials provider, we are a partner that can add value to all stages of a medical device product lifecycle.

Identifying New Opportunities

Utilizing multiple approaches to gain insight into patient and clinician challenges and health economic impact.

Developing Materials and Components

Developing materials, components or devices that address key challenges focusing on improved outcomes at reduced costs.

Validating Performance

Collaborating with universities and our partners to determine performance criteria and address risks.

Supporting Regulatory Processes

Partnering to identify regulatory pathways in support of fast tracking clearance.

Expediting Market Adoption

Generating clinical evidence and collaborating with KOLs to drive market adoption; offering our partners technical, marketing and sales support.

Bringing a device to market?

Our team of experts is here to help
Contact an expert
Success Stories

Hear what practicing surgeons are saying about fracture fixation devices made from carbon fiber composite material, PEEK-OPTIMA Ultra-Reinforced

It's reset my expectations for bone healing. When I go back to using a standard implant for whatever reason, I'm disappointed. I don't see the same healing that I do when using PEEK-OPTIMA Ultra-Reinforced.

Adam W. Rives, MD
Orthopedic Surgeon
Liberty Orthopedics, Liberty, MO

With better visibility you get better assurance that what you’re seeing is what you’re really seeing, and you can progress people a little faster.

Joshua Niemann, MD
Orthopedic Surgeon
Dickson-Dively, Orthopedics Kansas City, MO

I think for the patient, knowing that their implant is strong enough to last long enough is a huge benefit... patients are scared about needing additional  surgery because something isn’t quite right or fixation failing,  plates breaking, screws breaking because the material wasn’t strong enough.

David Hak, MD, MBA
Orthopedic Surgeon Denver Health,
University of Colorado Denver, CO

What I’ve seen in my practice is that osteoporotic patients who are smokers, who are not healthy people, are having the same healing rates or better than patients who are young, healthy with standard metal implants.

Adam W. Rives, MD
Orthopedic Surgeon,
Liberty Orthopedics, Liberty, MO

The greatest benefit (Perioperatively) is ease of visualization...you can actually see the reductions. You’re not obscuring the joint surface or the bone fragment

Timothey M. Badway, MD
Orthopedic Surgeon
Clinical Professor University of Missouri, Kansas City, MO

stop

TRAUMA APPLICATIONS

Our proven, biocompatible carbon fiber composite material, PEEK-OPTIMA Ultra-Reinforced polymer may offer the potential to enhance healing in challenging patients. Read more about the applications where this innovative material is currently utilized.

peek-optima™ materials

PEEK-OPTIMA™ polymer blends proven performance with superior wear, safety and comfort. Since Invibio introduced PEEK-OPTIMA as the first implantable PEEK polymer in 1999, it has earned the confidence and gained the acceptance of the global medical community.

PEEK-OPTIMA™ Ultra-Reinforced

PEEK-OPTIMA™ Ultra-Reinforced

For over 15 years and approximately 9M devices implanted worldwide, the high-performance implant-grade polymer, PEEK-OPTIMA Natural has been utilized in spinal fusion applications, predominantly in the form of load-bearing interbody fusion devices. With continued innovation PEEK-OPTIMA Natural polymer is reinforced with carbon fibers, forming a composite material where the stiffness can be tailored, resulting in treatment options that are less rigid than equivalent all metal constructs.1 The result is an ultra-strong alternative to metal traditionally used in internal fracture fixation procedures.

Metal has been used for internal trauma fixation for decades, with generally good outcomes. However, complications related to non-unions, delayed unions and implant failure continue to be a challenge3 – especially for higher risk patients. Now there is a material with greater fatigue life that may extend the time before implant failure and increase the potential for healing.2 Compared to metal, PEEK-OPTIMA Ultra-Reinforced polymer provides:

  • Tailored stiffness1
  • Similar mechanical strength1
  • Greater material fatigue life1
  • Earlier and greater callus formation2
  • Radiolucency and artifact-free imaging
  • Increased accuracy of radiotherapy dosing in cancer patients4

Compared to metals typically used in anatomic trauma plates, PEEK-OPTIMA Ultra-Reinforced polymer may provide:

  • 50x Greater Fatigue Resistance1 – increasing the window of opportunity to union
  • 150% Greater Callus Formation2 – which may improve secondary healing
  • 360° Fracture Visibility – for insight during reduction and postoperatively
Surgeon Trauma Brochure

References

  1. Data on file with Invibio – Mechanical Benchmark of Carbon Fiber PEEK-OPTIMA Ultra-Reinforced vs Ti 6AI-4V Plates undergoing Static and Dynamic Testing per ASTM F382-99 (2008)
  2. Jo Wilson, PhD; Matthew Cantwell; Polyetheretherketone (PEEK) Carbon Fiber Composites May Improve Healing of Fractures Stabilized with Intramedullary Nails. (Basic Science Focus Forum, paper #4, 2014) 155
  3. CE Henderson et al. Locking plates for distal femur fractures: is there a problem with fracture healing? (J Orthop Trauma, 2011 Feb 25) Suppl 1:S8-14.doi: 10.1097/BOT.0b013e3182070127
  4. Biagini, 2014. The Use of Carbon-Fiber Reinforced PEEK Orthopedic Devices and Implants in Cancer Patients Who Undergo Radiotherapy: A Report From the Italian Orthopaedic Society (SIOT) Bone Metastasis Study Group.
PEEK-OPTIMA™ Reinforced

PEEK-OPTIMA™ Reinforced

PEEK-OPTIMA Reinforced polymer consists of short carbon fibers dispersed within the PEEK-OPTIMA Natural matrix to provide properties well suited for distal radius, proximal humerus and other extremity plates. The resulting material has enhanced mechanical and physical properties for more demanding load-bearing implants and applications.

Selected published studies demonstrate:

  • Improved functional outcomes vs. conventional locking plates
  • Significantly better outcome scores (OSS and CMS) at 2 year follow-up for patients treated a CFR-PEEK proximal humerus plate vs. patients treated with a conventional locking plate1
  • Fewer complications vs. conventional locking plate
  • Loss of reduction with subsequent varus deformity less frequently observed in patients treated with a CFR-PEEK proximal humerus plate vs. a conventional locking plate1
  • No cases of hardware breakage or loss of reduction at 12-month follow-up in patients treated with a distal radius plate2 and no cases of fatigue failure with proximal humerus3
  • Visibility in all radiographic planes of cortices and screws with potential to improve surgical technique, follow-up clinical assessment,2,3 and reduce the risk of primary screw perforation1
  • Limited osseointegration, facilitating plate removal2
Contact an expert

References 

  1. Schleimann B et al. Treatment of proximal humerus fractures with a CFR-PEEK plate: 2-year results of a prospective study and comparison to fixation with a conventional locking plate. J Shoulder Elbow Surg. 2015 Aug;24(8):1282-8. doi: 10.1016/j.jse.2014.12.028
  2. Tarallo L et a. A new volar plate made of carbon-fiber-reinforcedpolyetheretherketon fo rdistal radius fracture: analysis of 40 cases. J Orthop Traumatol. 2014 Dec;15(4):277-83. doi: 10.1007/s10195-014-0311-1
  3. Rotini R. Proximal humeral fracture fixation: multicenter study with carbon fiber peek plate. Musculoskelet Surg. 2015 Sep;99 Suppl 1:S1-8. doi:
    10.1007/s12306-015-0371-2.
The materials on this site are intended for Heath Care Professionals and industry users only. If you are a patient, click here, otherwise, click continue.