FDA clears Centric Medical’s hammertoe device

Centric Medical, the foot & ankle division of Life Spine, said today it won FDA 510(k) clearance for its Hammertoe Correction System.

The newly cleared system is designed to be inserted between the proximal and middle phalanges so opposing threads fixate on the phalangeal canal of the to to compress the joint, the Huntley, Ill.-based company said.

“Due to the advanced technology in this Hammertoe Correction System, the implant provides maintained correction through stability and compression at the PIPJ, and avoids the complications associated with K-wires,” Dr. Kyle Pearson of Rezin Orthopedics said in prepared remarks.

The company touted the system as a significant advancement from the standard of care, which consists of using wire pins which are exposed out the end of the phalanges for multiple weeks.

Centric Medical said it plans to launch the device in September this year.

In June, Centric Medical said it won 510(k) clearance from the FDA for its subtalar arthroereisis implant for treating flatfoot deformities.

The device is a 1-piece titanium implant designed to block forward, downward and medial displacement of the talus to allow normal articulation of the subtalar joint. The device is slated for limited release at the end of this year, with a full product launch expected in the 1st quarter of 2017, the company said.

Centric said the clearance is the 4th it’s won in a year from the federal safety watchdog.

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