Ceterix Orthopaedics Inc.

Article preview from Start-Up - March, 2013

The meniscal suture passer from Ceterix Orthopaedics Inc. is a handheld surgical instrument that due to its small size and design facilitates meniscus repair. Because it leaves the cushion of the meniscus intact, the company believes its device will help patients avoid the arthritic changes that frequently accompany meniscus removal.

Ceterix Orthopaedics Inc.

Article preview from Start-Up - March, 2013

The most common arthroscopic procedure performed in the US is surgery on the knee meniscus, which is injured mostly by sports trauma that forcefully twists or rotates the knee. Meniscus repair totals roughly one million surgeries annually. However, about 85% of these procedures are a meniscectomy, whereby all or part of the torn meniscus is removed. This is because orthopedic surgeons who specialize in sports medicine lack a suturing system that is able to maneuver effectively within the tight knee compartment to provide suture patterns to treat different types of tears without meniscus removal.

The meniscal suture passer from Ceterix Orthopaedics Inc. is a handheld surgical instrument that due to its small size and design makes it easier and quicker for the surgeon to suture a meniscus tear. The use of this device will likely improve patient outcomes because of suture pattern, according to company president and CEO John McCutcheon, who believes about 600,000 of the one million patients needing meniscus surgical repair in the US are candidates for the device, representing an annual potential market of between $800,000 and $1 billion. “Although a patient initially feels great after a meniscectomy, 10 to 15 years later that patient will develop arthritis,” McCutcheon says. “You end up with bone on bone after removal of the meniscus. Our suture passer avoids arthritis down the road because the cushion of the meniscus remains intact.”

The Ceterix suture passer was released as a class I 510(k) exempt device in January, for a version that does not have built-in suture capability. “The surgeon loads commercially available suture during the procedure,” McCutcheon says. A class II 510(k) clearance is expected in late 2014 for a more advanced system that is fully loaded with suture. CE mark is anticipated in mid-2014.

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