Profile: Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft tissues. We offer a variety of programs and services to help hospitals better manage the purchasing process, from inventory management to data cleansing and electronic pricing systems. Our trauma implants and instruments are used for the surgical treatment of fractures, deformities and tumors of the long bones (arms & legs),the shoulder, hand,foot and the pelvis. Our product portfolio comprises of plates, screws, cannulated screws, intramedullary nails, a comprehensive range of external fixators, and products for the hip & condyles. We offer surgeons a broad range of implants and instruments for the treatment of fractures, tumors, deformities, and degenerative diseases affecting the spine.

The company was founded in 1974, has revenues of > USD 1 Billion, has ~9000 employees. SWF:SYST (SEC Filings)

FDA Registration Number: 3003506883

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• Human Bone Rasps (FDA Code: HTR / 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.

• Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD / 888.3690) A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (888.3027). This device is not intended for biological fixation.

• 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.

• Incubator/ Water Bath (FDA Code: JTQ / 866.2540) A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.

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

• Intervertebral Disc Prosthesis (FDA Code: MJO)

• Intracompartmental Pressure Monitor (FDA Code: LXC)

• 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.

• Laparoscopic Probes

• Laser Power Probe

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Limb Cover (FDA Code: IPM / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

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

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• 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.

• Metal Mesh (FDA Code: EZX / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Metal/Polymer Cemented Non-Constrained Shoulder Prosthesis (FDA Code: KWT / 888.3650) A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).

• Metallic Non-Spinal Nut Bolt Washer (FDA Code: NDG / 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.

• Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300) Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

• Monofilament & Multifilament Steel Non-Absorbable Suture (FDA Code: GAQ / 878.4495) A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030)

• Nail Extractors (FDA Code: HWB / 888.4540)

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

• Non-Alterable Preformed Skull Bone Plate (FDA Code: GXN / 882.5330) A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

• Non-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850) A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

• Nut Bolt Washer (FDA Code: HTN / 888.3030)

• One-Piece Scalpel (FDA Code: GDX / 878.4800)

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Fixation Accessories (FDA Code: LYT / 888.3030)

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

• Orthopedic Osteotome (FDA Code: HWM / 878.4800)

• Orthopedic Spatula (FDA Code: HXR / 878.4800)

• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)

• Passer (FDA Code: HWQ / 888.4540)

• Periodontal Probes

• Pin Surgical Driver (FDA Code: GFC / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ / 878.4820)

• Polymeric Surgical Mesh (FDA Code: FTL / 878.3300)

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Protractor (FDA Code: HTH / 888.4600) A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.

• Proximal Femoral Fixation Implant Device (FDA Code: JDO / 888.3030)

• Reamer (FDA Code: HTO / 888.4540)

• Rechargeable Replacement Battery (FDA Code: MOQ / 878.4820)