EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a representation of human profiles. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 23, 2016 Encore Medical, L.P. % Teffany Hutto Manager. Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758 Re: K161945 Trade/Device Name: EXPRT Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension(40mm) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 22, 2016 Received: August 24, 2016 Dear Ms. Hutto: 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/Resourcesfor You/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, # Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | | 510(k) Number (if known) | K161945 | | Device Name | EXPRT Revision Knee Femoral Augment (5mm) EXPRT Revision Knee Stem Extension (40mm) | | Indications for Use (Describe) | Joint replacement is indicated for patients suffering from disability due to:<br>• degenerative, post-traumatic or rheumatoid arthritis;<br>• avascular necrosis of the femoral condyle;<br>• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;<br>• moderate valgus, varus or flexion deformities;<br>• treatment of fractures that are unmanageable using other techniques.<br>This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.<br>Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement. | | Type of Use (Select one or both, as applicable) | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." FORM FDA 3881 (8/14) Page 1 of 1 {3}------------------------------------------------ ## 510(k) Summary Date: September 23, 2016 Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758 Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com | Product | Classification | Product Code | Product Code | Regulation and Classification Name | |----------------------------------------------------------------------------------------|----------------|--------------|--------------|------------------------------------------------------------------------------------------------------------------| | Exprt Revision Knee Femoral Augment (5mm)<br>Exprt Revision Knee Stem Extension (40mm) | Class II | JWH | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented<br>prosthesis per 21 CFR 888.3560 | #### Description: This Special 510(k) is to add additional components to the currently cleared Exprt Revision Knee. These components are as described as follows: A 5mm thick, machined, Ti alloy, distal femoral augment which will be available in 4 sizes. The augment covers either the posterior femoral resection in a horizontal orientation or the distal femoral resection in a vertical orientation and fits within the cement pocket of the femoral component. A shorter cemented stem extension for use with both the tibial base plate and the femoral component. The stem, made from CoCrMo alloy, is fluted along its length for rotational constraint when cemented. The stem is available in a 40mm long, straight configuration. ### Indications for Use: Joint replacement is indicated for patients suffering from disability due to: - degenerative, post-traumatic or rheumatoid arthritis; . - avascular necrosis of the femoral condyle; . - post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy; - moderate valgus, varus or flexion deformities; . - . treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications. Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement. #### Predicate Devices: DJO Surgical Foundation Knee Augment Blocks - K941306 DJO Surgical Exprt Revision Knee - K140830 {4}------------------------------------------------ ### Comparable Features to Predicate Device(s): These components are comparable to the predicate devices in indications, material, design features, surgical implantation technique, intended use, packaging, and sterilization. Key Differences in Subject Device to Predicate: Femoral stem augments: Different method of fixation to predicate. Stem extension: Shorter length than predicate. Endotoxin Assessment: Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits. Non-Clinical Testing: Analyses were performed which included drawing review with tolerance stack ups and anatomic bone model evaluation. All evaluations have determined that the devices are substantially equivalent to the applicable predicate devices. Clinical Testing: Clinical testing was not required.