OrthAlign Plus System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 1, 2016 OrthAlign, Incorporated Mr. David Vancelette Director of Quality Assurance & Regulatory Affairs 120 Columbia, Suite 500 Aliso Viejo, California 92656 Re: K153237 Trade/Device Name: OrthAlign Plus® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 29, 2016 Received: February 2, 2016 Dear Mr. Vancelette: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### K153237 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K153237 Device Name OrthAlign Plus® System #### Indications for Use (Describe) The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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FORM FDA 3881 (8/14) Page 1 of 1 {3}------------------------------------------------ ## 3. 510(K) SUMMARY This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c). | DATE | January 29, 2016 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | APPLICANT | OrthAlign, Inc.<br>120 Columbia<br>Suite 500<br>Aliso Viejo, CA 92656<br>Tel: (949) 715-2424<br>Fax: (949) 831-9500 | | OFFICIAL<br>CORRESPONDENT | David Vancelette<br>OrthAlign, Inc.<br>120 Columbia,<br>Suite 500<br>Aliso Viejo, CA 92656<br>dvancelette@orthalign.com<br>Tel: (858) 692-0335<br>Fax: (949) 831-9500 | | TRADE NAME | OrthAlign Plus® System | | COMMON NAME | Stereotaxic Instrument | | DEVICE<br>CLASSIFICATION | Class II, 21 CFR §882.4560 | | PRODUCT CODES | OLO: Orthopedic Stereotaxic Instrument | | PREDICATE<br>DEVICES | OrthAlign Plus® System (K140331)<br>Aesculap OrthoPilot Next Generation (K141694) | | SUBMISSION TYPE | Traditional 510(k). The subject device is a modification<br>to the previously cleared OrthAlign Plus® System<br>(K140331). | ### SUBSTANTIALLY EQUIVALENT TO: The OrthAlign Plus® System is substantially equivalent to the previously cleared OrthAlign Plus® System (K140331) and Aesculap OrthoPilot Next Generation (K141694). # DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. {4}------------------------------------------------ The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. In total knee arthroplasty procedures, the device assists the surgeon in: - Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus angle ● and the posterior slope angle of the cutting block relative to the tibia. In hip arthroplasty procedures, the device assists the surgeon in: - Establishing the orientation of the anterior pelvic plane and determining the ● inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane. - . Measuring the intraoperative change in leg length and offset (posterior approach). In unicompartmental knee arthroplasty procedures, the device assists the surgeon in: - Establishing the mechanical axis of the tibia, determining the varus/valgus angle ● and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation. ### INDICATIONS FOR USE: The OrthAlign Plus® System has the same indications for use as the previously cleared OrthAlign Plus® System (K140331). Additional functionality has been added to the predicate device to enable the navigation of tibial transverse resections in unicompartmental knee arthroplasty. Also, Indications for Use are common to the Aesculap OrthoPilot Next Generation (K141694). Thus, the Indications for Use are as follows: ### OrthAlign Plus® System: The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - . Total Hip Arthroplasty: Anterior/Posterior - Unicompartmental Knee Arthroplasty: Tibial transverse resection {5}------------------------------------------------ # TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE): The OrthAlign Plus® System was cleared under K140331. The OrthAlign Plus® System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen. The OrthAlign Plus® System is being updated to include navigation functionality for unicompartmental knee arthroplasty, tibial transverse resections, as in the predicate device Aesculap OrthoPilot Next Generation (K141694). All other features and principles of operation remain unchanged. ## PERFORMANCE DATA: Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed only the added Unicompartmental instruments and surgical procedure steps. Performance testing included: - . System hardware verification/validation testing to ensure the instruments meet their mechanical requirements. - Instrumentation cleaning, sterilization and shipping validations for the specified processes. - . Navigation device sterilization, packaging, shelf life, environmental conditions and shipping validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced.) - System components biocompatibility assessment per ISO 10993-1 (2009). ● - Customer requirements / usability validation in cadaver with an advising surgeon to . validate the system meets design input requirements for its functions in a simulated use environment. - . System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy. This testing regime demonstrates that the subject device is as safe and effective as the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in the accurate navigation of tibial resection planes in unicompartmental knee arthroplasty. The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus® System is substantially equivalent to predicate devices such as the OrthAlign Plus® System (K140331) and Aesculap OrthoPilot Next Generation (K141694). {6}------------------------------------------------ # BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE: A technological comparison and bench and cadaver testing demonstrate the substantial equivalence of the OrthAlign Plus® System to the predicate devices. The subject device is identical to the predicate OrthAlign Plus® System (K140331), with the following exceptions: - . The subject device allows for the navigation of tibial resection planes in unicompartmental knee arthroplasty. The subject device is substantially equivalent in terms of unicompartmental knee arthroplasty function to the predicate device Aesculap OrthoPilot Next Generation (K141694).