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: Patient Specific Talus Spacer
HDE Applicant: Additive Orthopaedics, LLC
Address: 44 Riverdale Avenue
Monmouth Beach, NJ 07750
Approval Date: February 17, 2021
Approval Letter: Approval Letter
What is it?
The Patient Specific Talus Spacer is an additively manufactured implant intended to match the patient's talus, a bone in the ankle joint that connects the leg and foot. The implant allows a patient with avascular necrosis (AVN) of the ankle joint to regain motion and reduce pain without an amputation or fusion until the time a fusion is necessary. The Patient Specific Talus Spacer is made from cobalt chromium metal alloy.
How does it work?
The Patient Specific Talus Spacer is designed to match the anatomy of the patient’s ankle bone and replace the patient’s damaged AVN talus. Movement in the ankle joint can occur where the distal tibia and the Patient Specific Talus Spacer connect.
When is it used?
The Patient Specific Talus Spacer is used in adult patients only who have AVN of the ankle joint.
What will it accomplish?
The Patient Specific Talus Spacer provides probable benefits related to improvement in pain with AVN talus patients who have limited treatment options and are high risk for fusion or amputation. The clinical data found the rate of reoperation was low, with 9.4% of cases (total of 32 cases, 31 patients) resulting in reoperation or correction.
When should it not be used?
The Patient Specific Talus Spacer should not be implanted in patients who have:
- Use of implant greater than 6 months from date of patient’s CT scan.
- Degenerative changes in the ankle, hindfoot, or midfoot joints.
- Presence of an active infection.
- Gross deformity in sagittal (right to left) or coronal (front to back) planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% partial dislocation anteriorly or posteriorly of the talus in the sagittal plane.
- Osteonecrosis in bones that support the ankle joint.
- Known history of existing malignancy, 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 the patient’s ability or willingness to activities or follow directions post-surgery during the healing period.
- Presence of neurological deficit which would prevent patient compliance post-surgery.
- Sensitivity or allergy to the metal implant. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity should be ruled out prior to implantation.