Orthopaedic Implants are designed and manufactured by Stryker Orthopaedics, Stryker Osteosynthesis, Stryker Spine and Stryker Biotech and consist of such products as implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; bone cement; and the bone growth factor OP-1. Artificial joints are made of cobalt chromium, titanium alloys, ceramics or ultrahigh molecular weight polyethylene and are implanted in patients whose natural joints have been damaged by arthritis, osteoporosis, other diseases or injury. The Company’s OP-1 bone growth factor induces the formation of new bone when implanted into bone, is composed of recombinant human OP-1 and a bioresorbable collagen matrix.
The Company’s reconstructive implants are suited to minimally invasive surgery (MIS) procedures that are intended to reduce soft-tissue damage and pain while hastening return to function. The Company supports surgeons with technology, procedural development and specialized instrumentation as they develop MIS techniques. The Company’s surgical navigation systems are used in MIS procedures to improve the accuracy of measurements and to position the implant. The Company’s Triathlon Total Knee Minimally Invasive Instrumentation is designed to complement the invasive total knee procedure pioneered by an orthopaedic surgeon. The Triathlon Partial Knee Resurfacing (PKR) unicompartmental knee system and the Avon Patellofemoral Joint are resurfacing, bone-conserving designs that are used to treat disease isolated to one compartment of the knee.
Stryker’s product portfolio includes products, such as OP-1, a recombinant version of a signaling protein with multiple tissue regeneration properties and TissueMend, a single-layer acellular collagen matrix. It also includes HydroSet, a bone substitute technology; BoneSource BVF, an osteoconductive bone substitute with biocompatibility and mechanical stability, and BoneSave, a granules-based alternative to bone grafting.
Through Stryker Orthopaedics, the Company offers a range of hip implant systems for the global reconstructive market including primary (or first-time) and revision (to repair or improve a previous replacement) hip systems, as well as hip systems. During the year ended December 31, 2007, the Company began selling the Cormet Hip Resurfacing System in the United States pursuant to a 10-year marketing and distribution agreement with Corin Group PLC. These products represent a less invasive, joint preserving hip resurfacing option for younger patients with the potential for improved stability and range of motion. In hip resurfacing procedures, very little bone is removed from the femoral head, the femoral neck is preserved and the femoral canal is spared.
The Company offers a system of cementless stems, cemented stems and acetabular cups for each of its primary hip implant technologies, including ABG, Partnership, Secur-Fit, Omnifit, Accolade, Exeter and Trident hip systems. These systems, along with associated surgical instrumentation, are designed to provide personalized solutions based on the patient’s anatomy while streamlining the implant procedure to improve surgical efficiencies. Each of these systems includes a portfolio of primary stem options based on multiple fixation philosophies, including anatomic, fit/fill, taper wedge and double-tapered designs. In addition, acetabular systems, including the Trident and ABG Acetabular systems provide a range of options for achieving initial and long term fixation. During the year ended December 31, 2008 the Company introduced the Tritanium Primary acetabular system. This system provides an advanced fixation technology offering a pure titanium matrix designed to improve bone ingrowth. Stryker has also introduced the X3 polyethylene. X3 polyethylene is the Company’s crosslinked polyethylene, which features a level of strength and wears reduction in both hip and knee replacements.
The Company offers a number of products designed to meet the needs of revision hip procedures, including Restoration, Restoration Modular, Trident Tritanium Revision, and Dall-Miles each of which provides surgeons with the options necessary to address revision surgery challenges. The Restoration Modular Revision Hip System offers surgeons performing revision surgeries flexibility in treating complex hip stem revisions and restoring patient biomechanics. The Restoration Modular Revision Hip System also takes advantage of Stryker’s clinical history with hydroxylapatite (HA), a naturally occurring calcium phosphate material that demonstrates a high level of biocompatibility due to its resemblance to bone, by incorporating PureFix HA coating on many components. The Restoration Modular Revision Hip System improves the Company’s existing Restoration HA and Restoration plasma spray (PS) monolithic revision systems. The Restoration System is complemented by the Trident Tritanium Acetabular Cup, a biologically inspired, commercially pure titanium ingrowth surface designed to provide solid initial fixation and promote bone ingrowth. Coupled with the availability of the Dall-Miles System for trochanteric reattachment and cerclage fixation, Stryker’s revision portfolio offers solutions to address challenges encountered in revision surgery.
The Company’s CentPillar Hip System offers a range of motion and an invasive technique preferred by Japanese surgeons for their patients. In 2007 the Company introduced CentPillar TMZF to the Japanese market.
Knee replacement surgery is a procedure intended to replace damaged articular bone surfaces in the knee joint often due to arthritis. The components used frequently are a femoral component, a tibial tray, a tibial bearing insert, and a patella bearing. Knee replacement surgeries also include primary procedures and revision procedures. Primary procedures tend to focus on the knee’s articular surfaces, whereas revision procedures can include simple replacement of one or more previously implanted devices, implantation of different devices to accommodate certain instabilities in the joint or larger reconstruction of the joint in severe cases.
The Company offers three knee implant systems: Triathlon, Scorpio, and Global Modular Replacement System (GMRS) systems. These implant systems were complemented in 2008 with the introduction of the Triathlon PKR unicompartmental knee system and the continued rollout of the Triathlon Total Stabilizer (TS) revision knee system and the Company’s X3 bearing technology for both Triathlon and Scorpio. The Triathlon PKR unicompartmental knee system was designed to resurface specific areas of the knee while leaving other healthy areas intact. It combines surgical instrumentation specifically designed for minimally invasive surgery with the single radius articular design and X3 advanced bearing material.
The Triathlon Knee System represents the Company’s evolutionary design that has been developed to more closely reproduce natural knee motion and is designed to provide mobility with stability through more than 150 degrees of flexion. The Triathlon Primary Knee system gives surgeons versatile instrumentation options that provide both accuracy and efficiency in a minimally-invasive approach, as well as options for treating varying degrees of instability in the knee. In 2007 the Company introduced the Triathlon condylar stabilizing (CS) version designed to provide extra stability where the posterior cruciate ligament is either weak or missing. The Triathlon cruciate-retaining (CR) version allows for retention of a functioning posterior cruciate ligament. The Triathlon posteriorly stabilized (PS) version provides a mechanical substitution for the posterior cruciate ligament, for an even greater degree of stability. The instrumentation for Triathlon is designed to improve operating room efficiency through a streamlined, integrated system providing options and flexibility to meet surgeons’ different preferences and multiple surgical techniques. In 2007, Stryker introduced the Precision instrument kit, specifically designed to improve surgical efficiencies through a sterile-packed disposable set of instruments, complimenting the existing Triathlon kits.
In 2007, the Company released the Triathlon TS revision knee system consisting of a comprehensive line of implants and instrumentation. Triathlon TS is designed to provide the surgeon options to deal with varying degrees of instability and bone loss in the knee, caused by either severe disease or revision of previous implants. It is also designed to provide the patient the ability to achieve the performance of a primary knee replacement in a revision application, again leveraging Stryker’s single radius design philosophy. Triathlon TS can be used with the X3 tibial insert, making it the only revision knee system on the market that offers cross-linked bearing material.
The Scorpio knee implant system is based on the Company’s design of a single articular radius based on the epicondylar axis of the knee. This approach addresses clinical issues, such as improved patient rehabilitation and mid-flexion stability, through the patella-femoral moment arm and a single anterior-posterior radius. The Scorpio system provides a range of options for the surgeon and patient in treatment of knee arthritis and stability. The Scorpio NRG provides an evolution in kinematic benefits, including increased rotational allowance and an articulating design enabling deeper flexion. In 2007, the Scorpio NRG with X3 advanced bearing technology was launched. This new version of the Scorpio NRG is designed to lower wear rates compared with standard inserts. The Scorpio System is supported by the X-Celerate instrumentation system, which was designed to provide intraoperative flexibility and precision, as well as an approach to total knee replacement surgery. Additionally, the Scorpio TS knee revision system provides surgeons the ability to address greater degrees of instability and bone loss in both primary and revision knee scenarios.
The GMRS knee implant system offers a solution for bone loss in oncology, trauma and revision surgery patients. GMRS has tibial and femoral components, including a total femur, and a modular rotating hinge knee. The system utilizes both titanium and cobalt chrome alloys for strength and lightness of weight, together with the superior flexibility of the hinge.
The Company markets other joint replacement products, principally shoulder and elbow implants and related instruments, under the Stryker brand name. The Solar Total Shoulder System was designed to address the common arthritic disorders affecting the shoulder, such as rheumatoid arthritis, osteoarthritis, posttraumatic arthritis and avascular necrosis. In cases of disease involving both the humeral head and the glenoid cavity with an intact rotator cuff, optimal pain relief and function may be achieved with total shoulder arthroplasty. In cases of cuff arthropathy, the Solar Bipolar, which incorporates the patented bipolar locking mechanism that is also used in the Company’s hip implants, was designed to fill the joint space and provide two articulating surfaces for better joint mechanics and pain relief. In 2007 the Company introduced the ReUnion Shoulder fracture system of implants and instrumentation. The ReUnion System utilizes a trial system to simplify the reconstruction of the shoulder during fracture surgery. The ReUnion’s body and fenestration enable the surgeon to use a range of suture techniques and improves healing. The Solar Total Elbow complements products offered for upper extremity procedures. The semiconstrained design and modular components address types of patient anatomy.
Simplex bone cement, a material used in cemented joint replacements, is used as bone cement in the world. The Company manufactures and provides several variations of Simplex bone cement to meet patient and clinical needs, including non-antibiotic and antibiotic versions.
Through Stryker Osteosynthesis, the Company develops, manufactures and markets its trauma extremities and deformities systems. These systems, including nailing, plating, hip fracture, external fixation systems and bone substitutes, are used primarily in deformity corrections and in the fixation of fractures resulting from sudden injury. These products consist of internal fixation devices marketed under such names as Gamma, Omega, Asnis, AxSOS, VariAx, HydroSet, BixCut, T2 and S2, along with external fixation devices marketed under the Apex, Hoffmann II, TenXor and Monotube Triax names.
The Company’s internal fixation product portfolio includes a range of IM nails, hip fracture devices and plates and screws in both titanium and stainless steel. These products complement the total hip and knee replacement offerings by offering a restorative option in addition to total joint replacement. To address the hip trauma and fracture segment, the Company markets several products, including the IM nail portfolio, led by the T2 Nailing System; the Gamma Nail, an IM nail for trochanteric fractures; the Omega hip screw system; the Asnis Cannulated Screw System; and the Hansson pin system, providing a complete offering of surgical solutions for the hip trauma patient. These hip fracture systems offer orthopaedic surgeons multiple options depending on their preferences and patient needs.
The T2 Nailing System includes femoral and tibial components with a common instrumentation platform for accuracy and ease of use. The Company has also introduced the T2 Ankle Arthrodesis Nail to provide the option for tibiotalocalcaneal fusion with a retrograde IM nail to repair limited soft tissue damage in the ankle area. 2007 the Company introduced the Omega3 Compression Hip Screw System, a product that reflects Stryker’s experience in the treatment of hip fractures of the proximal femur. The Omega3 system offers surgeons a choice of low-profile hip plates plus the option to lock screws with diverging fixation. The Omega3 allows surgeons to decide preoperatively or even intraoperatively to add axial stabilizing screws to lock the hip plate to the femoral shaft.
To address the knee trauma segment, Stryker offers the Hoffmann II Modular Fixation System, the T2 SCN Nailing System and the SPS and AXSOS plating solutions. The Hoffmann II knee-bridging frame is used to stabilize injuries to the knee until definitive treatment with a plate or nail occurs or reconstruction takes place. In addition, Stryker offers the T2 SCN Nail, which can be used for the treatment of supracondylar femur fractures just above the knee joint. This nail can also be used for periprosthetic fracture fixation for traumatic fractures in patients who have already had a joint replacement.
Stryker has several product lines for extremity trauma. The Universal Distal Radius System complements the stainless steel Numelock II with a titanium option in distal radius plates and screws. The Universal Distal Radius System offers a range of precontoured, variable-sized plates for volar, distal and column approaches and both open reduction and internal fixation techniques. In 2008 the Company extended its VariAx technology to both hand and foot applications. Both systems offer a plating system to treat multiple small bone fractures. The second-generation VariAx Universal Distal Radius System, which is thinner than the original and features polyaxial locking, was launched in 2006. The AXSOS Locking Plate System, also introduced in 2006, is designed to treat metaphyseal and diaphyseal fractures with anatomically contoured plates, a screw design and a simple instrument platform.
The Company’s external fixation products also include the Hoffmann II Compact and MicroFix, the Monotube Triax monolateral system, the TenXor circular fixation system for complex fractures and a complete range of pins and wires for attaching the devices to fractured bones. The Hoffmann II Compact for upper extremity fractures includes a snap-fit mechanism that makes it easy for surgeons to construct the fixation device to fit the patient and align the fractured bones. It also has a full selection of lightweight radiolucent connection bars that allow for quick intraoperative fracture repair. The Monotube Triax System is available in three sizes and includes an adjustable feature that enables surgeons not only to stabilize fractures but also to lengthen the bone in cases where bone has been removed due to damage. The TenXor hybrid frame enables surgeons to treat complex fractures around the joints with both pins and long transfixing wires. This attribute is useful for patients with multipart fractures near the ankle and knee. The system features composite materials and is compatible with the Hoffmann II snap-fit connection devices.
Through Stryker Spine, the Company develops, manufactures and markets spinal implant products including cervical, thoracolumbar and interbody systems used in spine injury, deformity and degenerative therapies. Spinal implant products include plates, rods, screws, connectors, spacers and cages, along with implant instrumentation. In 2008 the Company introduced the Radius Thoracolumbar Spinal Implant System. The Radius system provides a non-threaded wedgelock locking mechanism designed to reduce the potential for false locking and cross-threading and to improve the speed, ease and reliability of connecting rods to screws. Also in 2008, the Company launched Xia III, the next generation of its thoracolumbar spinal implant system and THOR, its anterior lumbar plating system that incorporates a screw locking technology. In 2007 the Company introduced the Mantis minimally invasive access system for posterior instrumented spinal fusion and the Reflex Zero Profile anterior cervical plating system.
Through Stryker Osteosynthesis, the Company develops, manufactures and markets plating systems and related implants, and products for craniomaxillofacial surgery. The Universal Fixation System is a plating system focused on anatomical regions of the face. The system offers a range of plates, screws, mesh and instrumentation for cranial and maxillofacial applications. The system is based on a universal concept that includes the SmartLoad screw field, the SmartLock locking system, and universal screwdriver blades and handles, each of which provides results and helps reduce surgical time. The Universal Trauma, Universal Mandible, and Universal Orthognathic modules provide sets for the surgeon. In 2007 the Company extended its Universal Fixation Portfolio with the addition of a neuro plating module. The Universal Neuro II System provides neurosurgeons with a range of plates. In 2008, the Company launched the DuraMatrix Onlay, an onlay specific dura substitute graft with improved conformability and handling characteristics.
Stryker’s therapeutic product, OP-1 Implant, is composed of recombinant human OP-1 and a bioresorbable collagen matrix. OP-1 is a natural protein that the human body makes to induce bone formation. In preclinical studies, OP-1 induced the formation of new bone when implanted into bony defect sites.
MedSurg Equipment products include surgical equipment; surgical navigation systems; endoscopic, communications and digital imaging systems, and patient handling and emergency medical equipment. These products are designed and manufactured by Stryker Instruments, Stryker Endoscopy and Stryker Medical. The Stryker Instruments and Stryker Endoscopy product portfolios include micro powered tools and instruments used in orthopaedics, functional endoscopic sinus surgery, neurosurgery, spinal surgery and plastic surgery. The Total Performance System (TPS) is a universal surgical system that can be utilized in medical specialties. The TPS U2 Drill and TPS Burs are designed for use by spine surgeons and neurosurgeons, while the TPS MicroDriver and TPS Sagittal Saw are designed for use by sports medicine physicians and plastic surgeons. The Elite attachment line with a extendable bur system and Saber Drill for (ear, nose and throat) ENT surgery further extend the TPS System into spine, neurosurgery and ENT applications. The TPS System also powers Stryker Endoscopy Shaver Systems.
Through Stryker Instruments, the Company offers a range of surgical, neurologic, ENT and interventional spine equipment that is used in surgical specialties for drilling, burring, rasping or cutting bone in small-bone orthopaedics, neurosurgical, spine and ENT procedures; wiring or pinning bone fractures; and preparing hip or knee surfaces for the placement of artificial implants. Stryker Instruments also manufactures a range of different attachments and cutting accessories for use by orthopaedic, neurologic and small-bone specialists.
In 2007, Stryker introduced the CORE Sumex drill, designed for use in ENT procedures, to further leverage the Company’s Consolidated Operating Room Equipment (CORE) platform. The Maestro drill represents Stryker’s line of micro powered instruments for spine, neurology and ENT applications.
Stryker Instruments also produces products that are utilized in conjunction with joint replacement surgery. These products include the Revolution Cement Mixing System, designed to provide one solution for mixing all surgical cements, in addition to offering mixing efficacy, safety and ease of use; the Interpulse, a disposable, self-contained pulsed lavage system used by physicians to cleanse the surgical site during total joint arthroplasty; and the ConstaVac CBC II Blood Conservation System, a postoperative wound drainage and blood reinfusion device that enables joint replacement patients to receive their own blood rather than donor blood. Through Stryker Instruments, the Company offers SpinePlex, a variation of its surgical Simplex bone cement for applications in the treatment of vertebral compression fractures.
Through Stryker Instruments, the Company offers a range of surgical navigation systems that give surgeons in several specialties the ability to use electronic imaging to see more clearly, better align instruments and track where the instruments are relative to a patient’s anatomy during surgical procedures. The eNdtrac ASM software and instrumentation give orthopaedic surgeons the option of navigating their cuts while eliminating the need to place additional pins in the femur and tibia outside of the surgical incision. The iNtellect software packages provide neurologic and ENT surgeons with improved graphics, procedure-specific workflows and tools for planning and navigation.
In 2007, the Company released the precisioN Knee 4.0 software to serve the knee implant market. This new software system represents an upgrade from earlier offerings and is designed to further simplify the procedure through reactive workflow by leveraging Stryker’s Smart instrumentation and camera technology. In craniomaxillofacial navigation, Stryker offers iNtellect Cranial and iNtellect ENT software. In 2008, the Company released SpineMap3D 1.0 software for spine navigation. SpineMap3D 1.0 software supports complex spine procedures, such as multiple-level scoliosis repair and less invasive cases, requiring intraoperative three dimensional (3D) CT data and is compatible with the intraoperative 3D C-arms for automatic registration. The Company offers the Navigation System II Cart, the eNlite suitcase system, which creates a smaller footprint in the operating room while retaining the functionality of all software programs offered on the Navigation System II Cart, and the Navigation iSuite, an integrated navigation system housed in the ceiling and walls of an existing operating room.
Stryker Endoscopy develops, manufactures and markets medical video-imaging and communications equipment and instruments for arthroscopy, general surgery and urology. The products include medical video cameras, digital documentation equipment, digital image and viewing software, arthroscopes, laparoscopes, powered surgical instruments, sports medicine instrumentation, radio frequency ablation systems, irrigation fluid management systems, i-Suite operating room solutions and equipment for telemedicine and enterprise-wide connectivity. Stryker’s line of rigid scopes, which range in diameter from 1.9 millimeters to 10 millimeters, contains a series of precision lenses, as well as fiber optics that, when combined with Stryker’s high-definition (HD) camera systems, allow the physician to view internal anatomy with a degree of clarity.
In 2008, the Company introduced the High Definition Digital Radiography (HDDR) 3000, a direct digital radiography system designed to accommodate the demanding requirements of modern orthopaedic practices. The HDDR 3000 features a Q-arm design with the x-ray tube always centered to the detector for the patient positioning. The system performs all general radiographic procedures with a single detector.
In 2007, the Company launched the Stryker Digital Capture (SDC) Ultra, an medical imaging information management system allowing for patient scheduling, video capture and storage, digital versatile disc (DVD) burning and more. The SDC Ultra archives surgical images and videos on its 250-gigabyte internal hard drive. This system also allows for the recording of all surgical footage in high-definition video. Through dual-channel input support, the SDC Ultra can capture images and video independently on two separate video channels, in synchronized mode or in picture-in-picture format. In 2007, the Company also introduced the 45L PneumoSure insufflator. The insufflator includes two additional modes for bariatric and vessel harvesting.
Stryker Medical offers a range of stretchers customized to fit the needs of acute care and specialty surgical care facilities. The Company offers the M-Series Stretcher, which incorporates the Company’s BackSmart side rail design elements, reducing the risk of back injury for caregivers; the Zoom Motorized Drive System, virtually eliminating push force; Big Wheel technology, reducing start-up force by up to 50% and increasing maneuverability; and a 700-pound weight capacity. The Company also offers the Pioneer Pressure Redistribution Surface for stretchers which incorporate self-adjusting air bladders to provide a preventative skin care solution and improve patient comfort. The Company’s Glide Lateral Air Transfer System allows two caregivers to easily transfer even the patients while reducing the risk for caregiver back injury by lifting and floating the patient on a cushion of air. Stryker furniture offerings, such as the Tru-Fit overbed table and Symmetry Plus Recliners, create a healing environment while providing functional design, comfort and reliable support.
Stryker Medical also develops and manufactures beds and accessories that are designed to meet the needs of specialty departments within the acute care environment. In 2008, the Company introduced the redesigned S3 Med/Surg Hospital Bed, the combining a retractable frame with the Company’s BackSmart ergonomically designed side rails and featuring an open architecture to accept any standard support surface. In 2007, the Company introduced the InTouch, the high-acuity care bed to combine advanced technology, intuitive operation and BackSmart ergonomics to the benefit of both patients and caregivers. Protocol Reminders, such as patient turn schedules are customizable to encourage practice to help improve patient outcomes. Stryker’s XPRT nonintegrated support surface with low air loss, percussion and rotational therapy aids in the prevention and treatment of certain skin ulcers and pulmonary care.
Stryker also offers the LD304 birthing bed, which features a removable foot section with the Lock-Rite System, and the Go Bed II MedSurg bed, which features low bed-height for safe patient ingress and exit. The Go Bed II also offers the Chaperone center-of-gravity bed-exit system with Zone Control to help prevent patient falls. Zone Control is a feature that enables the caregiver to adjust the sensitivity of the bed-exit system to accommodate different patient needs. Stryker has a complete line of intensive care unit (ICU) beds for critical care and step-down units. The beds incorporate features that facilitate patient care, such as in-bed scales that accurately weigh the patient regardless of bed position and a radiolucent surface that facilitates chest x-rays without moving the patient from the bed.
The Company competes with Johnson & Johnson, Zimmer Holdings, Inc., Biomet, Inc., Smith & Nephew plc, Synthes, Inc., Medtronic, Inc., KLS Martin L.P., Conmed Corporation, B. Braun Melsungen AG, BrainLAB AG, Tyco International Ltd., General Electric Company, Linvatec, Inc., Arthrex, Inc., Karl Storz GmbH & Co., Olympus Optical Co. Ltd., Hillenbrand Industries, Inc., Steris Corporation, Ohio Medical Instrument Company, Inc. and Ferno-Washington, Inc.