ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA

{0}------------------------------------------------ Zimmer Patient Specific Instruments System 5.4 510(k) Premarket Notification ### 510(k) Summary #### K133162 ### 510(k) Summary The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92 | Company name | Materialise N.V. | |-----------------------------------|-----------------------------------| | Establishment registration number | 3003998208 | | Street Address | Technologielaan 15 | | City | Leuven | | Postal code | 3001 | | Country | Belgium | | Phone number | +32 16 74 45 37 | | Fax number | +32 16 39 66 06 | | Principal Contact person | Oliver Clemens | | Contact title | Quality and Regulatory Officer | | Contact e-mail address | Regulatory.Affairs@materialise.be | | Additional contact person | Wim Claassen | | Contact title | Product Manager | | Contact e-mail address | Wim.Claassen@materialise.be | #### Submission date The date of the Traditional 510(k) submission is September 30", 2013. #### Submission information | Trade Name | Zimmer® Patient Specific Instruments<br>Zimmer® Patient Specific Instruments Planner | |--------------------------|-------------------------------------------------------------------------------------------------| | Common Name | Knee prosthesis | | Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi-<br>constrained cemented prosthesis | | Primary product code | JWH (21 CFR 888.3560) | | Subsequent product codes | MBH, OOG and OIY | #### Predicate Devices The predicate device to which substantial equivalence is claimed to: | Trade or property or model name | Zimmer® Patient Specific Instruments System 5.0 | |---------------------------------|-------------------------------------------------| | 510(k) number | K121640 | | Decision date | 12/05/2013 | {1}------------------------------------------------ Zimmer Patient Specific Instruments System 5.4 510(k) Premarket Notification | Product code | JWH, OOG (21 CFR 888.3560) | |--------------|----------------------------------------| | Manufacturer | Materialise NV<br>Materialise USA, LLC | #### Device Description The subject 'device Zimmer® Patient Specific Instruments System 5.4 is a modification to the predicate device Zimmer® Patient Specific Instruments System 5.0 (K121640) to accommodate the new compatible implant system Zimmer® Personalized Knee System Trabecular Metal™ components cleared via 510(k) K122745 and K121771. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persono™ Trabecular Metal™ components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI). #### Intended Use #### Total Knee Replacement The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural – Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only. #### Unicompartmental Knee Replacement The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only. The Zimmer® Patient Specific Instruments are intended for single use only. #### Functioning of the Device The Zimmer® Patient Specific Instruments System 5.4 generates a pre-surgical plan based on MRI image data sets using the Zimmer Patient Specific Instruments Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Zimmer Patient Specific Instruments are designed and manufactured based on the approved pre-surgical plan. Zimmer Patient Specific Instruments are patient specific templates which transfer the pre-operatively determined positioning of the chosen total knee replacement co the patient intra-operatively, assisting the surgeon in positioning and aligning the actual total knee replacement components by guiding and marking drill locations. {2}------------------------------------------------ Zimmer Patient Specific Instruments System 5.4 510(k) Premarket Notification #### 510(k) Summary #### Technological Characteristics A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the predicate devices. #### Performance Data Non-clinical tests using saw bones have been performed to assess the safety and effectiveness of the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Results of software verification and validation testing demonstrated the device's safety and effectiveness is substantially equivalent to the predicate device. #### Summary The characteristics that determine the functionality and performance of the Zimmer Patient Specific Instruments System 5.4, are substantially equivalent to the device cleared under K121640. The Zimmer Patient Specific Instrument System will be manufactured in compliance with FDA and ISO quality system requirements. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract eagle or bird-like figure with three curved lines representing wings or feathers. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 25, 2014 Materialise N.V. Mr. Oliver Clemens Quality and Regulatory Officer Technologielann 15 Leuven, Belgium 3001 Re: K133162 Trade/Device Name: Zimmer Patient Specific Instruments System 5.4 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, MBH, OOG, OIY Dated: January 23, 2014 Received: January 27, 2014 ### Dear Mr. Clemens: 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 {4}------------------------------------------------ ### Page 2 - Mr. Oliver Clemens 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 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, # Vincent - 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): K133162 # Device Name: Zimmer Patient Specific Instruments System 5.4 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments) ### Indications for Use: ### Total Knee Replacement The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural – Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only. ### Unicompartmental Knee Replacement The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only. The Zimmer® Patient Specific Instruments are intended for single use only. Page 1 of 2 {6}------------------------------------------------ Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Casey L. Hanley Ph.D. Division of Orthopedic Devices (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133162 Page 2 of _2_