ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM

{0}------------------------------------------------ K130810 (pg 1/3) P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131 #### Summary of Safety and Effectiveness SEP 19 2013 Sponsor: Contact Person: 200000000000000 Date: Trade Name: Common Name: Classification Name and Reference: Predicate Device: Device Description: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Scott M. Durlacher Principal Regulatory Consultant, Anson Group Telephone: (317) 569-9500 Fax: (317) 569-9520 July 12, 2013 Zimmer® MotionLoc™ Screw for Periarticular Locking Plate System Bone Screw Screw, Fixation, Bone (21 CFR § 888.3040, Product Code HWC) Periarticular Locking Plates and Screws, 2357 and 2359 Series, K042598, cleared October 29, 2004; Periarticular Locking Plates, 2358 Series, K043227, cleared December 10, 2004; Zimmer Periarticular Locking Plate System. Model 2357 and 2359. K050121. cleared January 31, 2005; Zimmer Periarticular Locking Plate System, K111039, cleared May 19, 2011; Smith & Nephew PERI-LOC™ Periarticular Locked Plating System Locking Bone Plates for Lower and Upper Extremity, K092015, cleared July 30, 2009; MotionLoc " Screw for NCB® Polyaxial Locking Plate System, K101696, cleared September 10, 2010; Zimmer® MotionLoc " Screw for NCB® Polyaxial Locking Plate System, K123918, cleared February 14. 2013 The Zimmer MotionLoc Screw for Periarticular Locking Plate System is used in conjunction with the Zimmer Periarticular Locking Plate (ZPLP) System. It is a member of the ZPLP Screw family and is used as an {1}------------------------------------------------ alternative for standard ZPLP Screws in applications where a surgeon desires reduced stiffness in a construct. Zimmer MotionLoc technology has been developed to reduce the stiffness of locked plating constructs while retaining construct strength. This Zimmer MotionLoc technology relies on a screw design with a reduced diameter mid-section. These screws provide uni-cortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate. The screw mid-section decreases the stiffness of the plating construct by acting as an elastic cantilever beam similar to a half-pin of an external fixator. The Zimmer MotionLoc Screw for Periarticular Locking Plate System has a standard ZPLP Screw front thread section (self-tapping, single helix); an expansion section, intended to create the gap for motion in the near cortex; a mid-section thread with a reduced core-diameter and reverse cutting flutes to aid in screw removal, especially once the front thread screw section is out of the far cortex; a non-threaded collar section; and a double lead threaded head for engagement in the plate. Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including: - Comminuted fractures ● - . Supracondylar fractures - . Intra-articular and extra-articular condylar fractures - Fractures in osteopenic bone . - Nonunions . - o Malunions The Zimmer MotionLoc Screw for Periarticular Locking Plate System is similar in intended use, sterility, and performance characteristics to the predicate devices. See the device description above for the design differences between the proposed and predicate devices. Intended Use: Comparison to Predicate Device: {2}------------------------------------------------ 40 Performance Data (Nonclinical and/or Clinical): Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective for their intended use and substantially equivalent to the predicate devices. Testing/analysis performed included: finite element analysis to assist in determining worst cases to test for physical testing; torsional fatigue -3.5mm Proximal Tibia Plate with Zimmer MotionLoc Screws; axial fatigue – 3.5mm and 4.5mm Proximal Tibia Plate with Zimmer MotionLoc Screws; starting load, driving torque, and torque to failure for Zimmer MotionLoc Screws. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the body and wings, with a smaller curved line representing the head and beak. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G603 Silver Spring, MD 20993-0002 September 19, 2013 Zimmer, Incorporated % Mr. Scott M. Durlacher Anson Group 9001 Wesleyan Road Suite 200 Indianapolis. Indiana 46268 Re: K130810 Trade/Device Name: Zimmer® MotionLoc" Screw for Periarticular Locking Plate System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 12, 2013 Received: July 15, 2013 Dear Mr. Durlacher: 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 cnclosure) 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 cither 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set {4}------------------------------------------------ Page 2 - Mr. Scott M. Durlacher 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm. Sincerely yours. # Anton E. Dmitriev For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known): K130810 (pg 1/1) Device Name: Zimmer® MotionLoc™ Screw for Periarticular Locking Plate System Indications for Use: Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including: - Comminuted fractures . - Supracondylar fractures . - Intra-articular and extra-articular condylar fractures � - Fractures in osteopenic bone . - Nonunions 0 - . Malunions Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) ## Elizabeth L. Frank -S Page 1 of 1 ו ז