Zimmer Periarticular Plating 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 an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 23, 2015 Zimmer, Incorporated Stephen McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 Re: K150121 Trade/Device Name: Zimmer® Periarticular Plating 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 Dated: January 16, 2015 Received: January 20, 2015 Dear Mr. McKelvey: 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150121 Device Name Zimmer Periarticular Plating System #### Indications for Use (Describe) Periarticular Plating System plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: comminuted fractures, supracondylar fractures, intra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions. Periaticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus. Periatioular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) - Over-The-Counter Use (21 CFR 801 Subpart C) ### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a stylized blue "Z" inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif font, also in blue. P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131 ## 510(k) Summary Zimmer, Inc. Sponsor: P.O. Box 708 Warsaw, IN 46581-0708 Contact Person: Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 372-4605 Date: January 16, 2015 Trade Name: Zimmer® Periarticular Plating System Common Name: Periarticular Non-locking Plates Classification Names Single/ Multiple Component Metallic Bone Fixation and References: Appliances and Accessories, 21 CFR 888.3030 (HRS) Classification Panel: Orthopedics/87 Predicate Devices: Zimmer Plates and Screws System (K140508, K143066) Zimmer Universal Locking System (K063303) Purpose and Device The Zimmer Periarticular Plating System consists of Description: temporary implants for the management of periarticular bone fractures through interfragmentary compression and bone plating. This submission covers various sizes of femoral, tibial, fibular, femoral, humeral, ulnar, and radial plates. Indications for Use: Periarticular Plating System plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the volar aspect of the distal radius, including associated carpal fusions. {4}------------------------------------------------ | | Periarticular Plating System Calcaneal plates are indicated<br>for complex extra-articular and intra-articular fractures<br>and osteotomies of the calcaneus. | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Periarticular Plating System screws are temporary internal<br>fixation devices designed to stabilize fractures during the<br>normal healing process. | | Comparison to Predicate Device: | The Zimmer Periarticular Plating System plates covered<br>by this submission are substantially equivalent to the<br>predicate devices, in that they have the same intended use,<br>function, and fundamental scientific technology. The<br>differences between the subject and predicate devices do<br>not raise new issues of safety or effectiveness. | | Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: | | | • Shelf Life - Accelerated aging testing conducted<br>shows that the sterile devices included in this<br>submission have a shelf life of 10 years. | | | • Biocompatibility – Biocompatibility testing of the<br>subject implant devices was conducted per ISO 10993-<br>1 and Good Laboratory Practices (21 CFR 58). All<br>testing passed. | | | • Performance Testing – Engineering analysis<br>demonstrates the devices are safe and effective and<br>substantially equivalent to the predicate devices. | | | Conclusions: The non-clinical performance data presented<br>in this submission show the subject devices will perform<br>in a substantially equivalent manner to the predicate<br>devices. | | | Clinical Performance and Conclusions: | | | Clinical data were not needed for these devices to show | substantial equivalence. 12