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  6. restor3d Total Talus Replacement – H230003
  1. Recently-Approved Devices

restor3d Total Talus Replacement – H230003

Example of the restor3d Total Talus Replacement (left) and its rendering in a CAD model after implantation (right)

 

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: restor3d Total Talus Replacement
HDE Applicant: restor3d, Inc.
Address: 311 W Corporation St, Durham, NC 27701
Approval Date: November 17, 2023
Approval Letter: Approval Order

What is it?

The restor3d Total Talus Replacement implant is a 3D printed and polished implant designed and made individually for each patient using data from computed tomography (CT) scan.

The restor3d Total Talus Replacement implant is intended to reduce pain, increase physical function and maintain range of motion by avoiding limb loss (amputation) or loss of joint mobility (fusion). The restor3d Total Talus Replacement implant is designed to match the patient’s specific anatomy and is additively manufactured from a medical grade cobalt chromium metal alloy. The device has optional soft tissue attachment sites to allow ligament attachment as needed.

How does it work?

The restor3d Total Talus Replacement implant replaces a patient’s native and diseased talus. This replacement allows the patient to maintain ankle joint movement between the distal tibia and the restor3d Total Talus Replacement implant, which imitates the anatomical talus in shape and size. As the diseased talus is replaced, pain is reduced. Optional soft tissue attachment sites may be requested and used by the surgeon to attach the patient’s related ligament(s) to the restor3d Total Talus Replacement implant.

When is it used?

The restor3d Total Talus Replacement Implant is indicated for:

  • avascular necrosis of the talus, the large bone in the foot that connects to the ankle
  • avascular necrosis of the talus in addition to talar collapse, cysts or non-union, which is an unhealed fracture
  • large, uncontained, unstable, or cystic talar osteochondral defects (bone damage) with risk of collapse or talar osteochondral defects not responsive to traditional treatments
  • non-union following talar fracture or talar extrusion, unresponsive to more conservative treatments

The implant is patient specific and is designed from CT scan. The anatomical landmarks necessary for the design and creation of the restor3d total talus replacement implant must be present and identifiable on CT scan.

What will it accomplish?

The clinical data suggest that the restor3d Total Talus Replacement implant provides probable benefit related to improvement in pain and physical function, as well as helping the patient maintain ankle joint range of motion. The rate of people needing additional surgery after the device implantation was 14.8%, and device survivorship was 96.3% in the provided clinical data. The device provides a clinically meaningful probable benefit to intended patients who have limited treatment options including fusion procedures with loss of ankle joint range of motion or amputation procedures with loss of limb.

When should it not be used?

The restor3d Total Talus Replacement should not be used for:

  • Surgical procedures other than those listed in the indications for use.
  • Device implantation more than 6 months after the patient’s preoperative CT scan.

It should not be used in people who have:

  • Degenerative changes in the tibiotalar, subtalar or talonavicular joints.
  • Severe (gross) deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane.
  • Active local or systemic infection.
  • Osteonecrosis of the calcaneus, distal tibia or navicular.
  • Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
  • Blood supply limitations and previous infections that may prevent healing.
  • Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage.
  • Conditions which may limit ability or willingness to restrict activities or follow directions postoperatively during the healing period.
  • Neurological deficit which would prevent patient postoperative compliance.
  • Foreign body sensitivity or suspected or documented material allergy or intolerance. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation.

Additional information (including warnings, precautions, and adverse events):

 

 
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