Anchorage 2 CP 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2015 Stryker GmbH Kurdea Lyon Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07423 Re: K151769 Trade/Device Name: Anchorage 2 CP System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 24, 2015 Received: September 25, 2015 Dear Kurdea Lyon: 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, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br><b>Indications for Use</b> | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | K151769 (page 1 of 1) | | | | Device Name | Anchorage 2 CP System | | | | Indications for Use (Describe) | The Stryker Anchorage 2 CP System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. | | | | Indications include: | <ul><li>Replantation</li><li>Joint fusions</li><li>Corrective osteotomies</li><li>Osteopenic bone</li></ul> | | | | Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF | |----------------------|-------------|----------------------------------------|----| |----------------------|-------------|----------------------------------------|----| {3}------------------------------------------------ | | 510(k) Summary | |-------------------------------------|-------------------------------------------------------------------------------------------------| | Submitter: | Stryker GmbH<br>Bohnackerweg 1<br>2545 Selzach<br>Switzerland | | Contact Person: | Kurdea Lyon<br>Regulatory Affairs Specialist<br>Phone: (201) 831-5996<br>Fax: (201) 831-3461 | | Name of Device: | Anchorage 2 CP System | | Common Name: | Bone Plates<br>Bone Screws | | Classification Name: | Single/multiple component metallic bone fixation<br>appliances and accessories 21 CFR §888.3030 | | | Smooth or threaded metallic bone fixation fastener<br>21 CFR §888.3040 | | Regulatory Class:<br>Product Codes: | Class II<br>HRS: Plate, Fixation, Bone<br>HWC: Screw, Fixation, Bone | | Predicate Devices: | Stryker Foot Plating System- K063875<br>VariAx 2 System- K141992 | | Reference device: | VariAx 2 System (partially threaded Ø2.7mm<br>VariAx 2 screw) - K132502 | | Date Prepared: | June 29, 2015 | #### Device Description This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance to market the new Anchorage 2 CP System. The Anchorage 2 CP System is an internal fixation device that consists of various plates used with compatible screws to treat different types of corrective osteotomies and fractures in the foot and ankle. The subject plates comprise of a new countersunk screw interface that is only compatible with the new inter-fragmentary partially threaded Cross-Plate (CP) lag screws. The subject components will be available sterile and non {4}------------------------------------------------ sterile. The plates will be available in sizes ranging from 23-49mm in length. The Anchorage 2 CP System is introducing Ø3.6mm and Ø4.1mm inter-fragmentary partially threaded Cross-Plate (CP) lag screws. The Anchorage 2 CP Ø3.6mm CP lag screws will be available in sizes ranging from 20-44mm in length and the Anchorage 2 CP Ø4.1mm CP lag screws will be available in sizes ranging from 20-70mm. The Anchorage 2 CP System includes holes that are only compatible with the existing VariAx 2 System screws that were previously cleared in the VariAx 2 System (K132502). Apart from the CP Lag screws, the associated accessories include: - . CP Reamer - CP Drill Guide for T8 Ø3.6mm CP lag screws . - CP Drill Guide for T10 Ø4.1mm CP lag screws . - . CP Templates ## Intended Use The Stryker Anchorage 2 CP System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. ### Indications for Use: The Stryker Anchorage 2 CP System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Indications include: - . Replantation - . Joint fusions - . Corrective osteotomies - . Osteopenic bone ## Comparison of Technological characteristics with the Predicate Device: The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously cleared Stryker Foot Plating System (K063875) and the VariAx 2 Systems (K141992 and K132502). The subject devices are substantially equivalent to the predicate devices in regards to design, materials, and operational principles for use in internal fixation, reconstruction, and treatment of fractures in the foot and ankle. {5}------------------------------------------------ #### Performance Data: #### Non-clinical Testing Biomechanical testing was performed on the Anchorage 2 CP System components to determine substantial equivalence. Testing demonstrated that the Anchorage 2 CP System is substantially equivalent to the predicate devices currently cleared for marketing. The following tests were performed: - Construct Fatigue Strength Testing as per ASTM F382-14 (Plates and CP Screws) . - . Insertion Torque Testing as per ASTM F543-13 (CP Screws) - . Shear-off Testing as per ASTM F543-13(CP Screws) - . Pull-out Testing as per ASTM F543-13(CP Screws) #### Biocompatibility Testing The biocompatibility evaluation for the Stryker Anchorage 2 CP System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993-1. "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests: - Cytotoxicity - · Sensitization - · Irritation The screws are categorized as per EN ISO 10993-1:2009 (E) as "Implant Device" with "Tissue/bone" contact duration > 30 days. The material is Titanium alloy (Ti6Al4V-ELI) as per ASTM F136. The plates are categorized as per EN ISO 10993-1:2009 (E) as "Implant Device" with "Tissue/bone" contact duration > 30 days. The material is commercially pure Ti as per ASTM F67. All Class II instruments are categorized as per EN ISO 10993-1: 2009 (E) as an "instrument" with "Tissue/bone" contact of duration <24 hours. ## Animal Testing Animal testing was not required for this submission. ## Clinical Testing Clinical testing was not required for this submission. {6}------------------------------------------------ #### Conclusion The subject device has the same intended use and similar technological characteristics as the predicate devices. The non-clinical laboratory data support the safety of the subject Anchorage 2 CP System and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject Anchorage 2 CP system is substantially equivalent to the predicate devices identified throughout this submission.