Profile: Signal Medical Corp. manufactures orthopedic surgical appliances. Our product area includes hip products, knee products, cable systems and instrumentation. The Micro Seal® acetabular component seals the interface between the shell and liner to protect the acetabular bone stock from joint fluid and wear debris. The osteogator provides a double action mechanism for maximum cutting force. Cable system allows sequential tensioning with multiple tensioners, thereby reducing wastage of cables. Our knee products include femoral components, tibial tray, liners, and screws. We also supply retractors, mallet, osteotomes, and double handed bone hook.
FDA Registration Number: 1836001
28 Products/Services (Click for related suppliers)
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• Bent Retractors |
• Bipolar Femoral Heads |
• 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. |
• Cancellous Bone Screw |
• Femoral Belts |
• Femoral Head-Neck Elevator |
• 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. |
• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 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. |
• Hip Positioner Systems |
• Hip Products, Osteogators |
• Inferior Acetabular Retractors |
• Knee Osteogators |
• Knee Products, Tibial Tray |
• 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. |
• Metallic Fixation Cerclage (FDA Code: NDD / 888.3010) |
• 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. |
• Phalangeal Hemi- Toe Prosthesis (FDA Code: KWD / 888.3730) A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe. |
• Rib Rongeurs (FDA Code: HTX / 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. |
• Semi-Constrained Femorotibial Knee Prosthesis (FDA Code: HRY / 888.3530) A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027). |
• Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 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). |
• Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 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. |
• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060) A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions. |
• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 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. |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ / 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. |
• Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LZO / 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. |