TRABECULAR METAL TIBIAL CONE AUGMENTS

{0}------------------------------------------------ K102896 (V3) ## DEC 1 3 2010 | Submitter: | Zimmer Trabecular Metal Technology, Inc.<br>10 Pomeroy Road<br>Parsippany, New Jersey 07054 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kathleen Rutherford<br>Associate Director, Regulatory Affairs<br>Telephone: (973) 576-0139<br>Fax: (973) 884-8792 | | Date: | September 30, 2010 | | Trade Name: | Trabecular Metal™ Tibial Cone Augments | | Common Name: | Knee joint patellofemorotibial polymer/metal/polymer semi<br>constrained cemented and uncemented | | Classification Name: | "Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis";<br>and<br>"Knee joint patellofemorotibial metal/polymer porous-coated<br>uncemented prosthesis" | | Reference: | 21 CFR § 888.3560, JWH and 21 CFR § 888.3565, MBH | ## DEVICE DESCRIPTION The existing, commercially available NexGen® Trabecular Metal™ Tibial Cone Augments are manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. The devices which are the subject of this 510(k), the modified NexGen Trabecular Metal Tibial Cone Augments are also manufactured of the same Trabecular Metal material, using the same methods as the predicate device. The existing, commercially available NexGen Trabecular Metal Tibial Cone Augments have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. A similar taper pattern is also present in the modified tibial cones. Both the modified tibial cones augments and the existing, commercially available tibial cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems- both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Tibial Bases and the tibial component of Zimmer's Rotating Hinge Knee (RHK) System. Fixation of all of the cone {1}------------------------------------------------ K102896(2/3) augments to the tibial implant is accomplished by cementing the superior portion of the augment to the underside of the tibial baseplate. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK tibial implant and with cement for the RHK tibial implant. With all of these tibial cone augments the LCCK tibial baseplate inferior surface must be cemented to the bone and the required stem extensions can either be cemented or press-fit. The existing, commercially available augments come in four medium & large sizes, two height options and stepped augments. They can be used in conjunction with Zimmer's LCCK or RHK Knee Systems. ### INDICATIONS FOR USE Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use. # DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S) Zimmer Trabecular Metal Technology, Inc. has submitted documentation demonstrating the substantial equivalence of the proposed implant to its predicate devices. The subject implant is identical to its predicate devices with respect to intended use/indications for use, materials, and basic principles of operation. ## PERFORMANCE DATA A comparative Finite Element Analysis (FEA) study was performed to determine whether the proposed design represented a worst case for the product line across different normal gait {2}------------------------------------------------ K102896(3/3) activities (walking and deep flexion). The results of testing and analyses conducted demonstrate that the proposed implants adequately meet the predetermined requirements established for its mechanical performance, supporting substantial equivalence to the predicate Trabecular Metal™ Tibial Cones. ## SUBSTANTIAL EQUIVALENCE The NexGen® Trabecular Metal™ Tibial Cone Augments product line extension is the same as the predicate devices with respect to intended use/indications for use, technological characteristics and basic principles of operation. As demonstrated by supporting tests and descriptions, this product line extension does not present any new issues of safety or effectiveness. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zimmer Trabecular Metal Technology % Ms. Kathleen Rutherford 10 Pomeroy Road Parsippany, New Jersey 07054 @EC 1 3 2010 Re: K102896 Trade/Device Name: Zimmer Trabecular Metal™ Tibial Cone Augments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 30, 2010 Received: September 30, 2010 Dear Ms. Rutherford: 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 or my 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 - Ms. Kathleen Rutherford 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/CDRH0ffices/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 yours, AZ B Rh Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K10289 b DEC 1 3 2010 Device Name: Trabecular Metal Tibial Cone Augment Indications for Use: Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use. 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) Page 1 of 1 for M. Wilkerson (Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102896 Zimmer TMT. Inc. Traditional 510(k) - Trabecular Metal Tibial Cone Augments Page 16 PROPRIETARY AND CONFIDENTIAL