restoris mck surgical technique

Results showed … We use cookies to customise content for your viewing and for analytics. endif; ?> Message from our President and Chief Operating Officer. Listening to patients and explaining the surgical options, benefits and risks after taking a full medical history, knee history, performing a physical exam, and reviewing appropriate knee imaging ; Computer software planning and adjustment for all the Mako Partial Knee Replacements; Optimizing the size, position, alignment, ligament balance and tracking of the Mako Restoris MCK … All product categories; Cranial; Neurovascular; back. It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. By continuing to use our site, … MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. var base_url = ""; It discusses the procedure for component sizing, bone preparation, trial reduction, cementing techniques, and component implantation. Your use of the other site is subject to the conditions of use and the privacy statement of that site. The letter identified the product, the problem, and the actions to be taken by the customer. Ensure that there is good pressurization of the cement to achieve good inter-digitation. enable_page_level_ads: true If you continue, you may go to another country site or a site that does not belong to Stryker. Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN. In October 2015, Perry received the Mako Restoris MCK knee implant during a total replacement surgery on her right knee. (adsbygoogle = window.adsbygoogle || []).push({ to surgical factors such as implant positioning and soft ... (Restoris MCK n=62) with those who underwent manually implanted PKA (Oxford n=58).16 Comparisons were made between groups in terms of the pre­operative plan of femoral and tibial component positioning against the actual alignment achieved in three different planes (axial, coronal, and sagittal). The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. }); FEMORAL COMPONENTS - UNICOMPARTIMENTAL KNEE REPLACEMENT, Complete classification of medical devices, Progressive number assigned to the medical device, End of validity is not present for the medical device. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English. RESTORIS MCK FEMORAL: Product Code: 180503: Manufacturer of the medical device: MAKO SURGICAL CORP. Category Name: FEMORAL COMPONENTS - UNICOMPARTIMENTAL KNEE REPLACEMENT: Category Code: P09090401: Sign repertoire: Registered: Group of similar Medical devices: 24976: Medical device reference: 0: Type: Medical Device Class : … For further information please read our cookie policy. Remove all extraneous cement and then keep the joint stable until cement cures. The surgical pathology report identified the defective knee implant as causing the failure. Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic … The products or services on different country sites may not be available or approved in your region or country. google_ad_client: "ca-pub-5568848730124950", For detailed instructions, please refer to RESTORIS ® MCK Planning and Surgical Technique Guide #20651. For questions regarding this recall call 954-628-0607. This guide to the surgical technique is a step-by-step procedure written for medial compartment UKA using the most widely adopted of the three techniques, the Spacer Block. An innovative, restorative surgical solution enables orthopedic surgeons to treat patient-specific, early to mid-stage osteoarthritic knee disease with consistent reproducible precision. The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. var tpl_folder = ""; Surgical visualization; Temperature management; Reconstructive surgery; back. Surgical treatment options for people suffering from the severe pain of a knee affl icted with osteoarthritis typically include either a total knee replacement or partial knee resurfacing. The product may be mislabeled and could result in the incorrect implant being used. if( $robots ) : ?> var site_url = ""; If you continue to browse this website, we will assume that you are happy to receive all our cookies. We use cookies to understand how you use our site and to improve your experience. We do not review or control the content of non-Stryker sites, nor are we responsible for any commercial activity or transactions on those sites. This includes personalizing content and advertising. According to the lawsuit, the knee implant was loosening significantly by May 2016. Wash the joint with pulse lavage and dry before cementing the final implants. You just clicked on a link to go to another website. It is strongly recommended that the surgeon read the complete … In June 2016, she required revision surgery to address the substantial damage. For questions, customers were instructed to call (954) 628-1721. 8. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. nce cement cures, … COVID-19 Response; Message from our President and Chief Operating Officer; Information for … All product categories; Spine; Craniomaxillofacial; Sports medicine; Foot and ankle; Joint Replacement ; Trauma & Extremities; back. To learn more, click here. Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, Code of Federal Regulations (CFR) Title 21 §7.55, 510(K)s with Product Code = NPJ and Original Applicant = MAKO SURGICAL CORPORATION, Instructions for Downloading Viewers and Players, Class 2 Device Recall Restoris Multicompartmental Knee (MCK) System.

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