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
• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 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. |
• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820) |
• Alterable Preformed Skull Bone Plate (FDA Code: GWO / 882.5320) A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. |
• Arthroscopes (FDA Code: HRX / 888.1100) An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint. |
• Arthroscopic Accessories (FDA Code: NBH / 888.1100) |
• Awl (FDA Code: HWJ / 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. |
• Bender (FDA Code: HXW / 888.4540) |
• Bending/Contouring Instrument (FDA Code: HXP / 888.4540) |
• Bone Clamp (FDA Code: HXD / 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. |
• Bone Fixation Nail (FDA Code: JDS / 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. |
• Bone Fixation Plate (FDA Code: HRS / 888.3030) |
• Bone Fixation Screw (FDA Code: HWC / 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. |
• Bone Fixation Staple (FDA Code: JDR / 888.3030) |
• Bone Hooks (FDA Code: KIK / 878.4800) |
• Bone Mallets (FDA Code: HXL / 878.4800) |
• Bone Rasps (FDA Code: HTR / 878.4800) |
• Bone Screw Starter (FDA Code: HWD / 888.4540) |
• Bone Staple Driver (FDA Code: HXJ / 888.4540) |
• Bone Taps (FDA Code: HWX / 888.4540) |
• Breathing Circuit Bacterial Filter (FDA Code: CAH / 868.5260) A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. |
• Broach (FDA Code: HTQ / 888.4540) |
• Burr Hole Cover (FDA Code: GXR / 882.5250) A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. |
• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045) A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. |
• Cement Dispenser (FDA Code: KIH / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites. |
• Cement Mixing Equipment (FDA Code: JDZ / 888.4210) A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027). |
• Compression Instrument (FDA Code: HWN / 888.4540) |
• Condylar Plate Fixation Device Implant (FDA Code: JDP / 888.3030) |
• Countersink (FDA Code: HWW / 888.4540) |
• Cranioplasty Plate Fastener (FDA Code: HBW / 882.5360) A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect. |
• Curettes (FDA Code: HTF / 878.4800) |
• Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone. |
• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800) |
• Drill Bit (FDA Code: HTW / 888.4540) |
• Drill Bits & Bone Taps |
• Electric ENT Surgical Drill (FDA Code: ERL / 874.4250) An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area. |
• ENT Trocar (FDA Code: KTE / 874.4420) |
• Fiberoptic Retractor (FDA Code: FDG / 876.4530) A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites. |
• Fixation Cerclage (FDA Code: JDQ / 888.3010) A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures. |
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300) |
• Forceps (FDA Code: HTD / 878.4800) |
• Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP / 888.3070) Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. |
• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators. |
• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820) |
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) |
• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820) |
• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800) |
• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800) |
• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800) |
• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800) |
• Guiding Probes |