Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws

{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 an eagle or a bird in flight, formed by three stylized human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 24, 2015 Zimmer, Incorporated Ms. Dorothy Snyder Associate Director, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 Re: K152841 Trade/Device Name: Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 28, 2015 Received: September 29, 2015 Dear Ms. Snyder: 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 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/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 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}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## Indications for Use 510(k) Number (if known) Device Name Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws Indications for Use (Describe) ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation of osteotomies and fractures, such as: - · comminuted fractures - · supracondylar fractures - · extra-articular fractures - · fractures in osteopenic bone - nonunions · malunions Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet. ZPS Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte 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 Druq 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 large, stylized blue letter "Z" enclosed in a blue circle. Below the circle, the word "zimmer" is written in lowercase, using the same blue color as the "Z" and circle. ## 510(k) Summary | Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dorothy Snyder<br>Associate Director, Trauma Regulatory Affairs<br>Telephone: (574) 372-4092<br>Fax: (574) 372-4605 | | Date: | November 16, 2015 | | Trade Name: | Zimmer® Plates and Screws (ZPS) Sterile 2.7mm Cortical<br>Screw | | Common Name: | Temporary Internal Fixation Devices | | Classification Names<br>and References: | Smooth or threaded metallic bone fixation fastener (21<br>CFR 888.3040, HWC) | | Classification Panel: | Orthopedics/87 | | Predicate Device(s): | Zimmer® Plates and Screws, Non-sterile 2.7mm cortical<br>screws cleared under K143066 on November 28, 2014.<br>Zimmer Plates and Screws System (ZPS) – Non-sterile<br>ZPS cleared under K143331 on March 04, 2015<br>Reference Predicate Only:<br>Universal Locking System, Sterile 2.7mm cortical screws<br>cleared under K063303 on November 22, 2006. | | Purpose and Device Description | The purpose of this submission is a line extension adding<br>the sterile version of the 2.7mm cortical screws cleared<br>under K143066. | | | System Description<br>The Zimmer Plates and Screws System (ZPS) is a<br>nonlocking, stainless steel plate and screw system. Plate | | | shapes vary to address varying patient bone sizes and<br>injury fragment sizes. Plates incorporate a spherical<br>sliding slope plate hole design to achieve the compression<br>required to treat bone fractures. The plates are used with a<br>variety of screws for temporary fixation to the bone. The<br>ZPS Washers are intended to prevent a screw head from<br>breaking through the cortex of the bone by distributing the<br>forces/load over a larger area when used for non-plate,<br>bone fragment, and fracture fixation | | Intended Use: | ZPS One-Third Tubular Plates, One-Quarter Tubular<br>Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-<br>Tubular Plates, Symphyseal Bridge Plates, Reconstruction<br>Plates, Contourable Dual Compression Plates, Cloverleaf<br>and Spoon Plates are indicated for temporary internal<br>fixation and stabilization of osteotomies and fractures,<br>such as:<br>• comminuted fractures<br>• supracondylar fractures<br>• extra-articular fractures<br>• fractures in osteopenic bone<br>• nonunions<br>• malunions | | | Smaller-sized ZPS plates are used for small bones and<br>small fragments of the hands and feet. | | | ZPS Calcaneal plates are indicated for temporary internal<br>fixation and stabilization of osteotomies and fractures of<br>the calcaneus. | | | ZPS and Forte Screws are temporary internal fixation<br>devices designed to stabilize fractures during the normal<br>healing process. | | Comparison to Predicate Device: | The subject ZPS screws are identical in intended use, basic<br>shape, compatible diameters, materials and performance<br>characteristics to their respective predicate devices, with<br>exception that the subject screws will be provided sterile. | | Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: | | | • Shelf Life - The implants that are supplied sterile have<br>a 10 year shelf life. Zimmer performs shelf life testing<br>based on FDA recognized consensus standards ISO<br>11607-1:2006 and 11607-2:2006. | {4}------------------------------------------------ {5}------------------------------------------------ - . Biocompatibility – Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed. - Performance Evaluation Because the sterile 2.7mm • ZPS screws are identical to the sterile version cleared under K063303 and identical (with exception to sterility) to those non-sterile screws cleared K143066, no additional mechanical testing was performed. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show substantial equivalence.