AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES

{0}------------------------------------------------ K112455 (1/2) # SEP 2 2 2011 VariAx® Distal Radius Locked Plating System Line Extension Aiming Blocks Special 510(k) # 510(k) Summary of Safety and Effectiveness: VariAx® Distal Radius Locked Plating System Line Extension for Addition of Aiming Blocks Howmedica Osteonics Corp. Sponsor: 325 Corporate Drive Mahwah, NJ 07430 Contact Person: Stephanie M. Fitts Sr. Director, Regulatory Affairs and Regulatory Compliance Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5405 August 16, 2011 Date Prepared: Proprietary Name: VariAx® Distal Radius Locked Plating System Line Extension for addition of Aiming Blocks Common Name: Bone plates and Screws Classification Name: Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §888.3030 Device Product Code:87 HRS: Plate, Fixation, Bone # Legally Marketed Device to Which Substantial Equivalence is Claimed: VariAx® Distal Radius Locked Plating System #### Device Description: This Special 510(k) submission is intended to add aiming blocks as an accessory to the VariAx® Distal Radius plate line which was cleared in K040022 and K100271. The aiming blocks are accessories used intra-operatively to guide the user in placement of the screws into the plate. There are 4 aiming blocks which correspond to the configurations of volar plates: Narrow Right, Narrow Left, Standard Right and Standard Left. The aiming blocks are used with a joystick tool which helps the user find the appropriate screw trajectory and is pinned in place once the desired alignment is obtained. Kirschner wires can also be used in conjunction with the aiming blocks to determine screw trajectory. # Intended Use: The VariAx® Distal Radius Locked Plating System Line Extension addition of Aiming Blocks does not alter the intended use of the predicate system as cleared in K040022 and K 100271. The indications for use for the subject plates are provided below. {1}------------------------------------------------ VariAx® Distal Radius Locked Plating System Line Extension Aiming Blocks Special 510(k) # Indications for Use: The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application. ### Summary of Technologies: The proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device. Addition of the aiming block as an accessory to the bone plating system does not alter the technology. ## Non-Clinical Testing: Benchtop testing was conducted to demonstrate that the use of the aiming blocks as described in the operative technique could withstand clinically relevant loads. Torque to failure was performed using the joystick and the block assembled and failure loads were found to be acceptable. Lateral loads were also placed on the construct and the failure mode was disassembly without significant damage to the plate. Biocompatibility testing of the materials in the aiming block assembly (PEEK and stainless steel) was conducted as well as cleanability testing, sterility testing and corrosion resistance testing. ## Clinical Testing: Clinical testing was not required for this submission. #### Conclusion: The VariAx® Distal Radius Locked Plating System Line Extension addition of Aiming Blocks are substantially equivalent to the predicate devices identified in this premarket notification. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above a wavy line, possibly representing water or movement. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Howmedica Osteonics Corporation % Dr. Stephanie Fitts Regulatory Affairs Associate 325 Corporate Drive Mahwah. New Jersey 07430 SEP 22 2011 Re: K112455 Trade/Device Name: VariAx® Distal Radius Locked Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 16, 2011 Received: August 25, 2011 Dear Dr. Fitts: 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 is 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 {3}------------------------------------------------ Page 2 - Dr. Stephanie Fitts CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetw/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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. Sincerely yours. Eunol Keith CoMark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ VariAx® Distal Radius Locked Plating System Line Extension Aiming Blocks Special 510(k) Indications for Use 510(k) Number (if known): K | 2 4SS Device Name: VariAx® Distal Radius Locked Plating System Indications For Use: The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraarticular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application. Prescription Use X AND/OR (21 CFR 807 Subpart C) Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Michael Oses to mxm (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Numbe