The reinforcing fibers enhance the materials structural integrity by providing added material toughness, allowing for drillability, and increasing the. Ra20104 hydroset injectable ha bone substitute all sizes page 2 of 7 in line with the recommendations of the meddev vigilance guidance document ref 2. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. Roberts and rosenbaum, bone grafts, bone substitutes and orthobiologics, organogenesis 2012.
We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. Stryker ems products prove themselves, year after year, in the most challenging realworld conditions. The sdc ultra simplifies file management by recording surgical photos and videos to compact digital media, such as cds, dvds, compact. It offers guidance that you should heed, but, as with any such technical guide. Hydroset is a calcium phosphate cement that converts to hydroxyapatite, the principle mineral component of bone. Cranios reinforced bone void filler is a biocompatible, selfsetting calcium phosphate cement intended to fill defects in the restoration or augmentation of the cranial skeleton. Norian drillable is a biocompatible, fiber reinforced, calcium phosphate, bone void filler that can be implanted either before or after final fixation, allowing flexibility of application. Formula handpieces formula handpieces also feature a bladerecognition system that eliminates the need for manually entering blade information and cutting speeds into the console. If requested by stryker, products or parts for which a warranty claim is made shall be returned prepaid to the factory.
Stryker stryker corporation or its subsidiary owns, uses or has applied for the following trademarks. Medical equipment stryker hydroset stepbystep manual. It has evolved from our extensive clinical experience with trauma devices, as. Apr 27, 2010 we present the case of a 71 year old man who developed knee pain and osteolysis around an uncemented total knee replacement. Bio4, dbm, hydroset, imbibe, stryker, vitross, vitoss bbtrauma. The crystalline structure and porosity offer osteoconductive and osteointegrative properties, with biocompatibility and mechanical characteristics. Hydroxyapatite bone cement application for the reconstruction.
Stryker interventional spine launches two new products to expanding portfolio. When revising an acetabular component, the initial mechanical stability of the construct is crucial to the overall success and. Hydroset is a selfsetting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. Always refer to the package insert, product label and. The products listed above are ce marked according to the medical directive 9342eec. Stryker medical equipment user manuals download manualslib. Hydroset injectable ha bone substitute stryker meded. New stryker 7943903 hydroset injectable implants and. Thats why, when you switch to stryker powerpro cots and powerload cot fastener systems, we make this proven to save promise. The stryker digital capture system ultra sdc ultra is a computerbased unit that records, manages, and archives digital images and videos of surgical procedures. Stryker corporation or its subsidiary owns the registered trademarks. Strykers customers quite literally put peoples lives back together.
Formulated to harden in the presence of water, blood and csf. User manuals, stryker medical equipment operating guides and service manuals. Hydroset is a calcium phosphate cement that hardens to form hydroxyapatite and remodels to natural bone through osteoclastic resorption and new bone formation. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient.
This document is intended solely for the use of healthcare professionals. Hydroset represents the next generation in bone substitute technology and is an excellent bone substitute solution for a wide variety of clinical applications and surgical specialties. The incidence of revision total hip arthroplasty tha continues to rise, as does the incidence of multiply revised implants. Hydroset injectable ha bone substitute stryker corporation.
Stryker corporation or its affiliates own, use, or have applied for the following trademarks or service marks. This manual is designed to assist you with the maintenance of the 1550 extended stay stretcher. The commercially available hydroset bone cement stryker inc. A workshop training is required prior to first surgery. Stryker does not offer medical advice, and we recommend healthcare personnel always undergo training prior to using any product on a patient. Stryker does not dispense medical advice and recommends that. The information presented is intended to demonstrate the breadth of stryker product offerings. Show all bone void fillers external fixation nailing plating screws shoulder. The stryker quikdrive mini is intended for inserting 1. Hydro set mixing instructions a stepbystep guide indications for use hydroset is a selfsetting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system i. An injectable, selfsetting bone substitute composed of tetracalcium phosphate that is formulated to convert to hydroxyapatite, the principal mineral component of bone. Hansson pin system medical equipment pdf manual download. It is designed to set under normal body wetfield conditions and produces hydroxyapatite as the final product. Hydroset is a selfsetting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system.
The white light illumination was used to visualize the vital tracer dye. Hydroset is specifically formulated to effectively set in a wet field environment and exhibits outstanding wetfield characteristics. Stryker, 397010, stryker hydroset injectable ha bone substitute, 10cc esutures. The rejuvenate femoral stem represents the latest evolution in the omnifit and securfit product lines, which has a successful published clinical history. Because the bony defect sight, hydroset was used for the voids.
Surgeon noted that the area was already infected before hydroset was placed in area. Hydroset injectable ha bone substitute craniomaxillofacial indications for use hydroset is a selfsetting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. Stryker patient handling equipment, measures must be taken to insure the stretchers are rinsed with clean water and thoroughly dried following cleaning. Stryker interventional spine launches two new products to. Following implantation, the formulation converts to hydroxyapatite, the principle mineral component of bone. Hydroset injectable ha bone substitute stryker cmf. Stryker does not dispense medical advice and recommends that healthcare professionals be trained in the use of any particular product before using it in a proceduresurgery. The system consist of two modules for the removal of almost any stryker trauma implant, as well as many non stryker plates, nails, and screws. The record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Failure to properly rinse and dry the stretchers will leave a corrosive residue on the surface of the stretcher, possibly causing premature corrosion of critical components. Develops, manufactures and markets specialty surgical and medical products internationally, and provides outpatient physical therapy services in the united states. Stryker reserves the right to alter, modify, amend, or terminate these benefits within the law, in a manner in which we believe to be in our and our associates best interest as affected by business conditions.
Toughness is defined as a measure of a materials resistance to fracture when stressed. The extraordinary surgeons and hospitals we serve make medical miracles part of a days work. Use filters to find rigged, animated, lowpoly or free 3d models. After one full year from your product shipment date, youll see at least a 50 percent reduction in injuries suffered when raising and lowering cots and a 50. Scanning electron microscope image of hydroset displaying a crystalline microstructure at 15000x magnification. As blades are inserted into the formula handpiece, the handpiece. This article presents a comparative analysis of the characteristics of different bone grafts substitute and talks about the widespread products used. Hydroset is indicated for bony voids or gaps that are not intrinsic to. Orthobiologics in orthopaedic trauma nonunion rate for fracture has been estimated at 5 10% recent literature suggests a 5% rate overall 14% in tibia. Stryker, 397005, stryker hydroset injectable ha bone substitute, 5cc esutures. This document is not for distribution in the usa stryker corporation or its subsidiary owns the registered trademark. Please contact your stryker representative if you have questions about the availability of stryker products in your area. All presented with autophony or sound andor pressureinduced vertigo, in addition to at least one physiologic measure consistent with scds.
A workshop training is recommended prior to first surgery. Hydroset is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Improving initial acetabular component stability in. Hydroset has a shorter set time than norian crs and norian crs fast set putty. Ct imaging was read as showing either dehiscence 36% or marked thinning of bone overlying the affected canal 64%. Hydroset is an injectable, fastsetting, osteoconductive hydroxyapatite ha bone substitute. Granuloma debridement and the use of an injectable calcium. Strykers obligation under this warranty is expressly limited to supplying replacement parts and labor for, or replacing, at its option, any product which is, in the sole discretion of stryker, found to be defective. Stryker corporation the company or stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Quik drive mini battery powered screwdriver osteosynthesis touch sensors for continuous. Abstract this study demonstrates the functional properties of norian drillable and other currently marketed calcium phosphate cements. Our trauma and extremities portfolio offers you marketleading implants for the treatment of long and small bone fractures, as well as extremity joint replacements. Mechanical test data on file with synthes, mechanical test number frn test 2. About your product product descriptionintended use the stryker crossflow integrated arthroscopy pump is a fluid management system illustrated below, the system is composed of a pump console with inflowonly and inflowoutflow modes, disposable cassette tubing, a wired hand control, and a wired footswitch the system integrates with.
One of the popular bone graft substitute, especially in spine surgery is calcium phosphate cements cpcs. Available in any file format including fbx, obj, max, 3ds, c4d. View and download stryker hydroset stepbystep manual online. Hydroset is indicated to fill bony voids or gaps of the skeletal system i. Hydroset is designed to offer rigidity, structure, and to. Stryker corporation or its subsidiary owns, uses, or has applied for the following trademarks. In the authors experience, this technique allows for better adherence of the cement to the bony edges. Hydroset norian crs norian crs fast set putty description. Large contained osteolytic acetabular defects can present a significant challenge to implant stability during revision tha 1, 2, 3. Hydroset represents the next generation in bone substitute technology intended for a wide variety of clinical applications in multiple surgical specialties. Improving initial acetabular component stability in revision. Paulos an orthopedic surgeon and former consultant at stryker alleges stryker and. Powerload users manual 30f4 details for fcc id z7a6390 made by stryker medical.
We present the case of a 71 year old man who developed knee pain and osteolysis around an uncemented total knee replacement. Stryker extraction system is a set of instrumentation developed to meet the surgeons need for implant extraction. Lia gonzalez senior regulatory affairs specialist stryker corporation 2 pearl court allendale, new jersey 07401 re. Stryker, 397010, stryker hydroset injectable ha bone. Hydroset extends the working period, which gives users more time for sculptingmanipulating and cement application. Hydroset hydroset is a fast setting osteoconductive hydroxyapatite bone substitute, which. Cranios reinforced norian crs hydroset stryker 700 600 500 400 300 200 100 0 cranios reinforced fast set putty cranios reinforced rotary mix. These defects may be surgically created or osseous defects created from traumatic injury to the bone.
Hydroset is a calcium phosphate cement that converts. The crystalline structure and porosity of hydroset makes it an effective osteoconductive material, with excellent biocompatibility and mechanical properties1. The bony structure has deteriorated over time and a revision surgery was done b 6 2006 to replace the implant. Indications cranios reinforced fast set putty and cranios reinforced rotary mix are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm cranios reinforced fast set putty and cranios reinforced rotary mix are also indicated for the. Due to significant medical comorbidies he was treated by percutaneous cyst granuloma debridement and grafting using.