Profile: Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult & pediatric deformity correction, internal & external racture fixation, biologics & bone growth stimulation, interbody fusion, & bracing. Our spine products are categorized as cervical, thoracolumbar, biologics, bone growth stimulation, and interbody fusion. Our Ascent® posterior occipital cervical thoracic system allows surgeons to address complicated fusion cases from the base of the skull to the thoracic region. While the occipital plate enables fixation to the occiput, the detailed engineering of the multi-axial screws and cross connectors simplify the procedure. The multi-axial screws feature 66 degrees of angulation, which minimizes rod contouring. The multi-plane adjustable cross connectors are pre-assembled and utilize a drop-in design for easy insertion. Our Spinal fixation system (SFS) provides simple, reliable and comprehensive stabilization solutions for spinal fixation. It is intended for non-cervical use in the spine.

The company was founded in 1980, has ~200 employees and is ISO certified. NASDAQ:OFIX (SEC Filings)

FDA Registration Number: 2183449

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• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Hand External Fixators

• Hinge Clamp

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Hybrid External Fixators

• Impactor (FDA Code: HWA / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Implants, Arthrodesis Nails

• Infusion Pumps, Ambulatory Pumps

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Intramedullary Fixation Rod and Accessories (FDA Code: HSB / 888.3020) An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

• Invasive Traction Component (FDA Code: JEC / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• K-Wire Guide

• Knee Soft Bracing Kit

• Knee/Ankle Braces & Supports

• Large External Fixators

• Lateral Cruciate Ligament Soft Bracing Kit

• LCL Soft Bracing Kit

• Limb Lengthening System

• Limb Reconstruction System

• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080)

• Lumbar Soft Bracing Kit

• Lumbosacral Back Braces

• Lumbosacral Braces

• Lumbosacral Orthosis (FDA Code: IPY / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

• MCL Soft Bracing Kit

• Medial Cruciate Ligament Soft Bracing Kit

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Meta-Diaphyseal Fixator

• Metal Laminoplasty Plate Spine Orthosis (FDA Code: NQW / 888.3050) A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

• Mini Bone Screws & Plates

• Minifixator

• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 888.3030)

• Non-Invasive Bone Growth Stimulator (FDA Code: LOF)

• Non-Invasive Electric Osteogenesis Stimulator

• Nuts And Washers

• Olive Washer

• Open End Wrench, 10 mm

• Ortho Wire Cutters

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Orthopedic Reconstruction Products

• Orthopedic Spatula (FDA Code: HXR / 878.4800)

• Orthoses, Lumbosacral Braces

• Pain Management Kits

• Pain Management System

• Patella Tendon Strap

• Patellar Tendon Strap

• Patellofemoral Soft Bracing Kit