Profile: Smith & Nephew Orthopaedics, Gmbh offers bone fixation screws, cement obturators, acetabular mesh hip prosthesis and orthopedic stereotaxic instruments.

FDA Registration Number: 8010764
US Agent: Jason Sells / Smith & Nephew, Inc.
Phone: +1-(901)-399-5520  E-Mail:

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• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 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.

• Acetabular Mesh Hip Prosthesis (FDA Code: JDJ / 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.

• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150) An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

• Antibiotic Bone Cement (FDA Code: MBB / 888.3027) Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

• Blood Bank Supplies (FDA Code: KSS / 864.9050) Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

• Bone Cement (FDA Code: LOD / 888.3027)

• 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)

• Calicum-Phosphate Non-Porous Metal/Polymer Uncemented Semi-Constrained Hip Prosthesis (FDA Code: MEH / 888.3353) A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• 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).

• Cement Monomer Vapor Evacuator (FDA Code: JDY / 888.4220) A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (888.3027).

• Cement Obturator (FDA Code: LZN / 878.3300)

• Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI / 888.3350) A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

• Cemented/Uncemented Semi-constrained Hip Prosthesis (FDA Code: MRA)

• 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.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• 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)

• 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.

• Image-Intensified Fluoroscopic X-Ray System (FDA Code: JAA / 892.1650) An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Implantable Clip (FDA Code: FZP / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Implantable Radiographic Marker (FDA Code: NEU / 878.4300)

• 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)

• Knee Joint Femorotibial Metal/Polymer Non-constrained Cemented Prosthesis (FDA Code: HSX / 888.3520) A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee 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 femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (888.3027).

• Metal Femoral Hemi- Hip Prosthesis (FDA Code: KWL / 888.3360) A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

• Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis (FDA Code: KWS / 888.3660) A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing 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).

• Metal/Polymer Constrained Hip Prosthesis (FDA Code: KWZ / 888.3310) A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (888.3027).

• Metal/Polymer Femoral Hemi- Hip Prosthesis (FDA Code: KWY / 888.3390) A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (888.3027) or implanted by impaction.

• Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LPH / 888.3358) A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

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

• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560) A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

• 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.

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 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.

• Orthopedic Stereotaxic Instrument (FDA Code: OLO / 882.4560)

• Orthopedic Surgical Table and Accessories (FDA Code: JEB / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Osteophilic Finish Uncemented Semi- Hip Prosthesis (FDA Code: MBL / 888.3358)

• Patellofemorotibial Knee Prosthesis (FDA Code: MBH / 888.3565) A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

• 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)

• Polymer Radial Hemi- Elbow Prosthesis (FDA Code: KWI / 888.3170) An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

• Polymer/Metal/Polymer Cemented Semi-Constrained Partial Knee Patellofemorotibial Prosthesis (FDA Code: NPJ / 888.3560) A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Powered Saw and Accessories (FDA Code: HAB / 878.4820)

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

• Radiofrequency Lesion Probe (FDA Code: GXI / 882.4725) A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.