510(k) Clearance for Plating System Line Extension

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a plating system line extension.

According to the 510(k) summary document, the device consists of “titanium plates (straight and T-plate) and locking /non-locking screws (1.3mm) and are offered in a range of configurations to accommodate patient anatomy.” Both the plates and screws are non-sterile. The plating system is “intended to bridge or otherwise stabilize bone fragments to facilitate healing.”

Tyber Medical LLC submitted the device for clearance. Tyber Medical is an orthopedic device manufacturer based in Bethlehem, Pennsylvania.

Tyber Medical Founder and CEO Jeff Tyber stated, “We expect this product to drive significant growth for our customers.”

This clearance expands the range of sizes for the Tyber Medical Mini-Frag System and is indicated for “fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle.”

The Mini-Frag System is also intended for “reduction and stabilization of non-load bearing long bone fragments.” It is not for spinal use.

Tyber Medical Sr. Director of World-Wide Strategic Partnerships Eric Dickson said, “The clearance for the additional plates and screws offers surgeons the ability to treat a larger population, specific to smaller anatomy.”

In order to qualify for 510(k) clearance the device must be substantially equivalent to a predicate device. Here, the DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm plates and screws) is listed as the primary predicate device. Two additional predicate devices were listed as Tyber Medical Anatomical Plating System.

The indications for use of the subject and predicate devices are similar. Additionally, the predicate devices and the subject device have the same technological characteristics. This includes design, material, chemical composition, and principle of operation.