Exactech wins FDA 510(k) for Optetrak knee prosthesis

Exactech (NSDQ:EXAC) said yesterday that it won FDA 510(k) clearance for its Optetrak Logic constrained condylar prosthesis for revision knee arthroplasty patients.

The knee prosthesis is approved for indications in patients undergoing total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, post-traumatic degenerative problems and to replace failed knee devices, the Gainesville, Fla-based company said.

“The FDA clearance of Optetrak Logic CC further expands the Exactech knee system offerings for surgeons who desire predictable and reproducible outcomes. Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss,” CEO David Petty said in a press release.

The Optetrak Logic system will have limited availability in 2015, with a full market launch slated for 2016, the company said.

In January, Exactech said it paid roughly $11.6 million to acquire BlueOrtho SAS, a French maker of computer-assisted surgical tech that has long been a development partner.

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