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# FDA Approves a World First Bone Implant
- URL: https://www.fdaweb.com/fda-approves-a-world-first-bone-implant/
- Published: 2021-02-18T12:00:00.000Z
- Updated: 2026-09-14T16:47:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148693

FDA has approved Additive Orthopaedics’ Patient-Specific Talus Spacer, a first in the world and first of its kind 3D-printed talus implant for humanitarian use to treat avascular necrosis (AVN) of the ankle joint. An agency [statement](https://www.prnewswire.com/news-releases/fda-approves-first-in-the-world-first-of-its-kind-implant-for-the-treatment-of-rare-bone-disease-as-a-humanitarian-use-device-301230287.html?ref=fdaweb.com) says the implant “provides a joint-sparing alternative to other surgical interventions commonly used in late-stage AVN that may disable motion of the ankle joint.”

The spacer is made for each patient individually, FDA says, modeled from CT imaging, and is fitted to a patient’s specific anatomy. During the replacement surgery, the patient’s talus bone is removed and replaced with the implant, which is made from a cobalt-chromium alloy.

FDA says it reviewed data for the talus spacer through the humanitarian device exemption process. Supporting data had results from 31 patients and 32 surgeries. At three years post-operation, the average reported pain score had decreased and the average range of motion in the ankle joint had increased.