NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. ## OCT 2 6 2011 K112174(1/2) P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131 #### 510(k) Summary Sponsor: Contact Person: Date: Trade Name: Common Name: Classification Names and References: Predicate Device: Device Description: Intended Use: Zimmer, GmbH Sulzer Allee 8 Winterthur, Switzerland CH-8404 Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760 July 26, 2011 NCB® Periprosthetic Femur Polyaxial Locking Plate System Locking Plate System Single/multiple component metallic bone fixation appliances and accessories - 21 CFR § 888.3030 NCB Periprosthetic Femur Polyaxial Locking Plate System The NCB Periprosthetic Femur Plate Provisional Instruments are surgically invasive, non-sterile, reusable devices used to determine the suitable implant length during intra-operative planning as part of the implantation of the NCB Periprosthetic Femur Plates. The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including: - . Periprosthetic fractures - . Comminuted fractures - Supracondylar fractures - Fractures in Osteopenic bone . - . Nonunions - . Malunions {1}------------------------------------------------ KII2174(2/2 Page 2 July 26, 2011 #### Comparison to Predicate Device: Performance Data (Nonclinical and/or Clinical): The modified NCB Periprosthetic Femur Polyaxial Locking Plate System contains the same implants and instruments as the original NCB Periprosthetic Femur Polyaxial Locking Plate System, except for the addition of new optional provisional instruments. Non-Clinical Performance and Conclusions: A bending test was performed to assess the behavior of the Provisionals under high handling force. The acceptance criteria were successfully met. Radiolucency and the physico-chemical stability of the polyphenylsulfone with barium sulfate material was compared before and after cleaning and sterilization cycles - results showed no discernable or significant differences between pre- and postprocessing. There was no evidence of surface changes, etch degradation, material deformation, significant dimensional changes and/or cracking of the provisional materials. The acceptance criteria were successfully met. Cytotoxicity of the polyphenylsulfone material with barium sulfate was evaluated post-processing. No leachable substances were released in cytotoxic concentrations from the test item. The acceptance criteria were met. In addition, this material has been used in prior orthopedic instrumentation with the same ISO 10993-1 classification and has a long successful history of clinical use. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of 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 OCT 2 6 2011 Zimmer, Inc. % Mr. Stephen McKelvey Senior Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 Re: K112174 Trade/Device Name: NCB® Periprosthetic Femur Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 3, 2011 Received: October 4, 2011 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 {3}------------------------------------------------ Page 2 - Mr. Stephen McKelvey 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/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/Resourcesfor You/Industry/default.htm. Sincerely vours. Erin I Keith ForMark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use ## 510(k) Number (if known): #### Device Name: NCB® Periprosthetic Femur Polyaxial Locking Plate System #### Indications for Use: The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including: - · Periprosthetic fractures - Comminuted fractures - Supracondylar fractures - · Fractures in osteopenic bone - · Nonunions - · Malunions ### Prescription Use _ X (Part 21 CFR 801 Subpart D) ## AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) #### 1, 15, 19 (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Richard Rivers 10/26/11 (Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112174 20