Orthopedic implant company Miach Orthopaedics has received 510(k) clearance from the FDA to update labeling of its BEAR knee implant.
The updated labeling includes a reduced risk of developing radiographically confirmed post-traumatic osteoarthritis following ACL injury compared to ACL reconstruction using hamstring tendon autograft, according to a Jan. 14 news release from Miach Orthopaedics.
The company collected data from two BEAR studies over six years, assessing the rate of radiographically confirmed post-traumatic osteoarthritis following the BEAR procedure compared with ACL reconstruction in patients aged 14 and older.
With the update, the BEAR Implant becomes the first sports medicine product to include a label claim related to reduced post-traumatic osteoarthritis risk, the release said.
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