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3D-Printed Patient Specific

Talus Spacer


The First and Only FDA Approved Patient Specific Talus Spacer in Multiple Materials

PATIENT SPECIFIC IMPLANT

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TALUS REPLACEMENT

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BENEFITS

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clinical data

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resources

Patient Specific Talus Spacer


The Paragon 28® Patient Specific Talus Spacer has two material options: a cobalt chromium metal alloy and a titanium alloy with a titanium nitride coating.

  • The FIRST FDA approved 3D Printed Total Talus Implant
  • The ONLY 3D Printed Total Talus Implant approved by the FDA in multiple materials
  • Expected to provide PAIN RELIEF and PRESERVE MOTION of ankle joint
  • Alternative to fusion or amputation
  • Indicated for Avascular Necrosis of the ankle
  • Patient specific technique guide provided for PRE-PLANNED anatomy correction
  • MULTIPLE IMPLANT SIZES provided for intra-operative selection
  • Surgeon choice of implant material
    • Cobalt Chromium
    • Titanium with Titanium Nitride coating

Total Talus Replacement

The Paragon 28 Patient Specific Talus Spacer is an alternative treatment option to fusion and amputation, and requires talus replacement surgery. During this procedure the native talus bone is removed and replaced with a 3D printed replica. This is considered a joint-sparing procedure, as it allows the patient to maintain motion of his/her ankle joint.

The First and Only FDA Approved

Patient Specific Talus Spacer in Multiple Materials

Explore our 3D printed, patient specific implant designed and made individually for each patient.

Paragon 28 Patient Specific Talus Spacer

The Paragon 28 Patient Specific Talus Spacer is an additively manufactured, or 3D printed, patient specific implant that is designed and made individually for each patient using CT image data.


Total Talus Replacement

An alternative treatment option to fusion and amputation, the Paragon 28 Patient Specific Talus Spacer is indicated for avascular necrosis of the ankle and requires total talus replacement surgery.

The procedure is designed to relieve pain and preserve motion in the ankle joint by replacing the patient’s damaged talus with a 3D printed replica of his/her bone. Talus replacement surgery is considered a joint sparing procedure as it allows the patient to retain motion in the ankle joint.

Potential Benefits of a Paragon 28 Patient Specific Talus Spacer

Reduce Pain

Improve Range
of Motion

Enjoy Recreational
Activities

Continue Your
Career

Better Quality
of Life

Patients who received a Paragon 28 Patient Specific Talus Spacer in the clinical study showed a reduction in baseline VAS Pain Scores, improvement in ROM, and improvement of functional outcomes based on FAOS subscales, including pain, symptom, activities of daily living, ability to perform sports and recreational activities, and foot/ankle related quality of life. Please refer to the IFU for complete Clinical Data Information.

Xiomalis’ Story

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Paragon 28 Patient Specific Talus Spacer


The Paragon 28® Patient Specific Talus Spacer has two material options: a cobalt chromium metal alloy and a titanium alloy with a titanium nitride coating. The Paragon 28 Patient Specific Talus Spacer in cobalt chromium is an additively manufactured implant made from cobalt chromium metal alloy and produced by laser sintering.

The Paragon 28 Patient Specific Talus Spacer in titanium alloy is an additively manufactured implant made from titanium alloy with a titanium nitride coating and produced by electron beam melting. The surgeon selects which material is best suited for his/her patient. The device allows the patient to regain motion and reduce pain without an amputation or fusion for the treatment of the current condition.

The Paragon 28® Patient Specific Talus Spacer has two material options: a cobalt chromium metal alloy and a titanium alloy with a titanium nitride coating. The Paragon 28 Patient Specific Talus Spacer in cobalt chromium is an additively manufactured implant made from cobalt chromium metal alloy and produced by laser sintering.

The Paragon 28 Patient Specific Talus Spacer in titanium alloy is an additively manufactured implant made from titanium alloy with a titanium nitride coating and produced by electron beam melting. The surgeon selects which material is best suited for his/her patient. The device allows the patient to regain motion and reduce pain without an amputation or fusion for the treatment of the current condition.

Patient

If you are a patient and want to learn about the benefits of a talus spacer and if it might be right for you, please click here.

Surgeon

If you are a surgeon and want to learn about total talus replacement and if it might be a good solution for your patients, please click here.

Clinical Data


Patients who received a Paragon 28 Patient Specific Talus Spacer in the clinical study showed a reduction in baseline VAS Pain Scores, improvement in ROM, and improvement of functional outcomes based on all FAOS subscales, including pain, symptom, activities of daily living, ability to perform sports and recreational activities, and foot/ankle-related quality of life. Please refer to the IFU for complete Clinical Data information.

Product Resources


File Download of SURGICAL TECHNIQUE GUIDE Patient Specific Talus Space

SURGICAL TECHNIQUE GUIDE Patient Specific Talus Space

Download

File Download of INSTRUCTIONS FOR USE Patient Specific Talus Spacer

INSTRUCTIONS FOR USE Patient Specific Talus Spacer

Download

File Download of Patient Information Guide – Paragon 28® Patient Specific Talus Spacer

Patient Information Guide – Paragon 28® Patient Specific Talus Spacer

Download

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