During shipping, it is possible for the aequalis ascend flex humeral stem to become unseated. Prior to use of any tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. The company is committed to delivering innovative, valueadded solutions improving the quality of life for patients worldwide. The implantation of a joint prosthesis and its associated implants requires. Biomechanics of the aequalis reversed ii prosthesis is designed for medialization of the center of rotation inside the glenoid bone surface. Aequalis reversed fx why do we need new members in the aequalis reversed family. Reversed indications the most extensive portfolio on the market. The tornier elbow prosthesis is intended for total elbow arthroplasty. Wright and tornier caution investors not to place considerable reliance on the forwardlooking statements contained in this presentation. Aequalis ascend flex prosthesis design mimics the internal humeral geometry and is the first humeral stem that is truly anatomic from the inside out. Use the distal tip of the guide handle to gain access to the humeral canal. Tornier, inc 10801 nesbitt ave s bloomington mn 554373109. The tornier glenoid system is a comprehensive offering that includes a variety of anchorage options such as a keel, standard peg and cortiloctm peg available in a variety of sizes. Unique stem shape designed from the inside out based upon ct data.
Tornier aequelis ascend flexx shoulder implant system on. The manufacturer recommends that all personnel responsible for handling and implanting the devices read and understand this information before use. Prior to use of any tornier implant system, the surgeon should refer to the product package insert for complete. Through its proximal fixation design, the aequalis ascend flex convertible. Aequalis ascend flex standard cemented humeral stems anatomic dwf702a 2a ascend flex standard cemented humeral stem dwf702b 2b ascend flex standard cemented humeral stem dwf702c 2c ascend flex standard cemented humeral stem dwf704a 4a ascend flex standard cemented humeral stem dwf704b 4b ascend flex standard cemented humeral stem dwf704c. Surgeons have control of height, version and fixation with system modularity and comprehensive trialing instrumentation. Urgent field safety notice for aequalis ascend flex shoulder system by tornier sas pdf, 5mb, file does not fully comply with accessibility standards. Tornier s aequalis ascend flex system was initially cleared by the fda in 20, and may be used in primary, reverse, or conversion from anatomic to reverse procedures. Prior to use of any tornier implant system, the surgeon should refer to the. The tornier aequalis ascend flex convertible shoulder system improves upon the traditional grammontstyle reverse total shoulder. The purpose of this multicentric study was to assess the outcomes and the radiographic results of a new, short, and convertible humeral stem aequalis ascend flex, tornier saswright medical inc, bloomington, mn, usa, which could settle these complex revision problems.
The ascend flex stem tornier inc is short 66 mm to 94 mm long and has proximal titanium plasma spray coating for metaphyseal pressfit. The system has been specifically designed to restore appropriate humeral to glenoid position, provide accurate preparation and deliver bone preservation. Forward flex the arm and place the richardson retractor under the conjoined tendon and gently retract it medially. The aequalis ascend flex shoulder system is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. Tornierasi annecy course scientific program annecy, france. Medical device aequalis ascend flex stem humeral ptc. Package inserts are also available by contacting wright. Reversed indications the most extensive portfolio on the.
Aequalis ascend flex shoulder system latitude ev elbow prosthesis salto talaris total ankle prosthesis cannulink intraosseous fixation system 59% 41% us international 59% 19%. The new system provides a short stem designed to match the. Proximal humeral bony adaptations with a short uncemented stem. The tornier glenoid has been designed to be compatible with the aequalis, affiniti and ascend. Shoulder arthroplasty featuring the aequalis ascend flex. Primary, reverse, conversion, biorsa, surgeon interview. Ascend humeral head systems in certain combinations. Aequalis ascend flex convertible shoulder system surgical. Tornier surgical technique guide copy charlotte shoulder. Medialization of the center of rotation inside the.
Universal instrumentation designed specifically for shoulder applications. The aequalis ascend flex convertible prosthesis has been carefully built upon the tornier legacy and clinical understanding of the aequalis anatomic and reversed systems. Wright featuring tornier technology wright medical group n. The aequalis ascend flex shoulder system is intended for use as. With the aequalis ascend flex system, conversion is often a simple exchange of components on top of the stem. The purpose of this multicentric study was to assess the outcomes and the radiographic results of a new, short, and convertible humeral stem aequalis ascend flex, tornier saswright medical. Ascend flex anatomic, cuff repair, aequalis reversed il, and latarjet tuesday 1st april 7. Learn more about primary total shoulder replacement and reverse total shoulder replacement with ascend flex. Be sure to insert the distal tip just medial to the. Figures 12 either the assistant or the scrub tech on the opposite side of the bed will hold the richardson retractor in place. Tornier aequalis ascend flex convertible shoulder system. The length is assembledfrom 120 mm using the short proximal bodyand stem to. Wright medicals shoulder, hand, forearm, and elbow products are chosen by surgeons around the world.
Ascend flex is an innovation in shoulder replacement design that gives your orthopaedic surgeon the flexibility to address your current shoulder condition while considering potential future conditions. Tornier reports second quarter 2014 results wright. Aequalis ascend flex reversed shoulder arthroplasty exposure. Tornier reports first quarter 2015 results and provides. It is indicated for patients who require shoulder replacement due to. Bfarm field corrective actions urgent field safety notice. Request pdf tornier aequalis ascend flex convertible shoulder system the tornier aequalis ascend flex convertible shoulder system improves upon. Revised caw6856 ascend flex humeral anatomic surgery 5 years ago. The aequalis ascend flex convertible prosthesis has been carefully built upon the tornier legacy and clinical understanding of the aequalis anatomic. The aequalis ascend flex shoulder system is indicated for use as a replacement of shoulder joints disabled by. Tournier shoulder replacement aequalis ascend flex simplicity.
Aequalis ascend flex reversed shoulder arthroplasty. Additionally, it is ideal to ream until a flat surface is created and. Wrights and tornier s businesses are subject to substantial risks and uncertainties, including those referenced above. Animation for tornier showing product features and basic overview. Torniers aequalis ascend flex system was initially cleared by the fda in 20, and may be used in primary, reverse, or conversion from anatomic to reverse procedures. The new system provides a short stem designed to match the internal geometry of the proximal humerus providing metaphyseal pressfit. The humeral entry point is located at the diaphyseal axis at the highest point of the humeral head. The humeral entry point is located at the diaphyseal axis at. Class 2 device recall aequalis ascend flex humeral stem. Searchable database of fda 510k applications and descisions. Ascend flex humeral head and ascend flex reversed trays and poly inserts. Ascend flex prosthesis design mimics the internal humeral geometry and is the first humeral stem that is truly anatomic from the inside out. The forwardlooking statements in this press release speak only as of the date of this release, and wright and tornier undertake no obligation to update or revise any of these statements.
Pdf a short and convertible humeral stem for shoulder. Brochures aequalis ascend flex simpliciti shoulder. By wright featuring tornier technology featuring james kelly february 2015 reversed shoulder arthroplasty exposure technique using aequalis ascend flex convertible shoulder system. The aim of this study was to quantify these phenomena using the ascend flex. Iorsa tm anle surgicl technique udrt151 7 surgicl techniue note. Tornier aequelis ascend flexx shoulder implant system on vimeo join. The aequalis ascend flex convertible prosthesis has been carefully built upon the tornier legacy and clinical understanding of the aequalis anatomic and.
Prior to use of any tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications, and adverse effects. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. Torniers flex shoulder system revised caw6856ascend. Identification of the humeral entry point the humeral head is generally deformed and anatomic reference points may be missing or distorted. Tornier shoulder replacement products include the ascend, aequalis ascend flex, and simpliciti lines.
There are not yet any outcome studies or ongoing clinical trials to our knowledge. Distalization of the humerus, resulting in retensioning of the deltoid muscle and any rotator cuff muscles that are still competent in case of massive rotator cuff tear. For more information on the cleared combinations refer to the mismatch charts listed below. Darren brown 9524267625 manufacturer reason for recall. At this point, proceed with releasing any subdeltoid adhesions. Should a conversion from a primary total shoulder to a reverse total shoulder be required, ascend flex features a convertible stem which allows for a simplified conversion, the already. For tornier shareholders, exchange ratio implies a per share value for tornier that represents a 28% premium to tornier s closing share price on october 24, 2014. The humeral length ismeasured todetermine the overall humeral implant construct length.
This website uses cookies to improve your experience while you navigate through the website. Trnx, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, reported today its. Prior to use of any tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications. By wright featuring tornier technology featuring james kelly february 2015 reversed shoulder arthroplasty exposure technique using aequalis ascend flex. Aequalis ascend flex convertible shoulder arthroplasty.
Reverse shoulder arthroplasty with a new convertible short stem. The medical device aequalis ascend flex stem humeral ptc long, size 3b, ang. Jan 22, 2016 tornier makes a short stem humeral component called the aquelis ascend flex tornier, edina, mn. Ascend flex wright tornier ascend reunion tsa 150,000 projected shoulder replacement surgeries in the u. Contact information can be found in this document and the package insert. Ascend flex anatomic, cuff repair, aequalis reversed il, and. The afr shoulder system is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. Aequalis ascend flex convertible shoulder system surgical technique. Aequalis reversed ii shoulder system wright medical group.
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