Profile: Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we deliver laparoscopists with product quality. Our Stryker MIS joint replacement program encompasses multiple MIS surgical techniques, MIS friendly implants, specialized instrumentation, comprehensive on-line and hands-on training & support. Our Simplex P Bone Cement provides a unique formula coupled with proprietary manufacturing. We also offer a full line of Conquest Arthroscopic Manual Instruments including punches, scissors and graspers to perform any arthroscopic surgery procedure and accommodate individual surgeon preferences. Our Bone Plug Cutter uses a circular design to harvest the bone-to-bone autograft with circular bone blocks. Our image-based technology used in spinal surgery utilizes scans of the patient's anatomy and instruments that are tracked by the navigation System's camera.
• Power Equipment |
• Powered Patient Rotation Bed (FDA Code: IKZ / 890.5225) A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation. |
• Pre Filled Bone Cement Mixer |
• Primary Femoral Components |
• Primary Shell/Cup Systems |
• Product Development, Hand-held Infusion Pump Controller |
• Product Development, Infusion Pumps |
• Proximal Femoral Fixation Implant Device (FDA Code: JDO / 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. |
• Radiographic Stretcher |
• Reamer (FDA Code: HTO / 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. |
• Reconstruction Cables |
• Removable synthetic spacers |
• Resectoscopes (FDA Code: FJL / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Resorbable Plating Systems |
• Retractors |
• Revision Femoral Components |
• Revision Shell/Cup Systems |
• Rigid Cystoscopes |
• Rotating Continuous Flow Resectoscopes |
• Routine Fiberoptic Light Source (FDA Code: FCW / 876.1500) |
• Saws (FDA Code: HSO / 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. |
• Saws Instruments |
• Screwdriver (FDA Code: HXX / 888.4540) |
• 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). |
• Semi-Rigid Ureteroscopes |
• Shoulder Holders |
• Silicone Penrose Drainage Tube |
• Silicone T-Y Drainage Tube |
• Silicone Y-Drainage Tube |
• Simplex Tobramycin Bone Cement |
• Sinus Cannula (FDA Code: KAM / 878.4800) |
• Sinus Endoscopy, Nasal Scissors |
• Sinus Suction Tips |
• Small Joint Arthroscopes |
• Small Open Gear Bone Drill |
• Soft Tissue Biopsy Needles |
• Stabilized Total Knee Systems |
• Stable Femoral Components |
• Standard Flow Resectoscopes |
• Static External Fixators |
• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise. |
• Sterile Irrigation Tray (FDA Code: EYN / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use). |
• Sterile Medical Grade Casting Material |
• Suction Canister Systems |
• Suction Catheter and Tip (FDA Code: JOL / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Suction Irrigator |
• Suction Tip |
• Suprapubic Tube Drainage (FDA Code: FFA / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar. |
• Surgical Blades |