Fusion Orthopedics Receives 510K Clearance on new Small Bone Plating System

Fusion Orthopedics is pleased to introduce the PolyLock Plating System as the newest addition to their product offering. FDA 510(k) clearance was issued November 18th, 2019. The assigned FDA 510(k) # for the Plating System is K192323.

The PolyLock System is indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

The PolyLock System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm and 2.7mm and lengths from 8mm to 26mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

The PolyLock Small Bone Plating System consists of nine different variations of plates and locking and non-locking screws that are used in the management of small bone orthopedic osteotomies, reconstruction, and traumas:

    1. Straight Plates
      • Plates range from 2-8 screw holes in seven different sizes.
    2. T-Plates
      • Plates range from 5-8 screw holes in four different sizes.
    3. Cotton Plates
      • Plates are offered in a single size with two holes and three wedged options ranging from 4mm to 8mm, with an additional neutral option.
    4. Evans Plates
      • Plates are offered in a single size with four holes and four wedged options ranging from 6mm to 12mm, with and additional neutral option.
    5. Hook Plates
      • Plate is offered in a single size with six holes.
    6. Jones Plates
      • Plate is offered in a single size with six holes.
    7. Navicular Plates
      • Plate is offered in a single size with eleven holes.
    8. Arch Plates
      • Plate is offered in a single size with six holes.
    9. Cuboid Plates
      • Plate is offered in a single size with eleven holes.
    10. Screw Specifications 
      • Both locking and nonlocking screws are offered in lengths ranging from 8mm to 30mm and is offered in three diameters (2.0mm, 2.4mm, and 2.7mm). The locking screw is designed with a threaded head that locks within the 6-scalloped holes. The nonlocking screws are designed to be used in both the locking holes and compression slots. The 2.0mm Locking Screw is offered in two variations; a screw with a torx driver connection and a screw offered with a hex driver connection. This variation is specifically intended for surgeon preference.

This FDA clearance highlights the accelerating growth of Fusion Orthopedics.  The company anticipates significant demand for the product as they round out a complete digital implant category solution with implants addressing most surgeon preferences.