Total Talus ReplacementParagon 28 Patient Specific Talus Spacer

Paragon 28 Patient Specific Talus Spacer

An additively manufactured, or 3D printed, patient specific implant
A novel alternative for patients suffering from AVN of the Talus
The FIRST and ONLY Paragon 28 Patient Specific Talus Implant approved by the FDA
total talus replacement
total talus replacement

Paragon 28 Patient Specific Talus Spacer

An additively manufactured, or 3D printed, patient specific implant
A novel alternative for patients suffering from AVN of the Talus
The FIRST and ONLY Paragon 28 Patient Specific Talus Implant approved by the FDA
PRODUCT DESCRIPTION

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 Paragon 28 Patient Specific Talus Spacer is an additively manufactured Paragon 28 Patient Specific Talus Implant.

  • The FIRST and ONLY Paragon 28 Patient Specific Talus Implant approved by the FDA
  • Indicated for Avascular Necrosis of the ankle
  • Provides pain relief and preserves motion of the ankle joint
  • Alternative to fusion or amputation
  • 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.

The Paragon 28 Patient Specific Talus Spacer is indicated for avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the Paragon 28 Patient Specific Talus Spacer must be present and identifiable on computed tomography (CT) scan.

Humanitarian Device. Authorized by Federal law for use in the treatment of avascular necrosis of the ankle joint. The effectiveness of this device for this use has not been demonstrated.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-world-first-its-kind-implant-treatment-rare-bone-disease-humanitarian-use-device

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