Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2015 Ortho Development Corporation Mr. Drew Weaver Director of Regulatory Affairs and Ouality Assurance 12187 South Business Park Drive Draper, Utah 84020 Re: K152169 Trade/Device Name: Balanced Knee® System Trimax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: July 31, 2015 Received: August 4, 2015 Dear Mr. Weaver: 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. Iisting 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. 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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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152169 Device Name Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts Indications for Use (Describe) The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications: - 1. Loss of knee joint configuration and joint function. - 2. Osteoarthritis of the knee joint. - 3. Rheumatoid arthritis of the knee joint. - 4. Post-traumatic arthritis of the knee joint. - 5. Valgus, varus, or flexion deformities of the knee joint. - 6. Revision procedures where other treatments or devices have failed. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <label><input type="checkbox"/> Residential Use (Dwelling, STR, MH, Cabin, etc.)</label> | <label><input type="checkbox"/> Other: Commercial/Health STR, MH, Cabin, etc.</label> | |------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| |× | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Business Park Drive Draper, Utah 84020 801-553-9991/fax 553-9993 orthodevelopment.com Image /page/3/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with three gray arcs above it, followed by the word "ORTHO" in purple, and the word "DEVELOPMENT" in gray below the word "ORTHO". The logo is simple and modern. # Section 5 # 510(k) Summary | NAME OF<br>SPONSOR: | Ortho Development Corporation<br>12187 South Business Park Drive<br>Draper, Utah 84020 | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) CONTACT: | Drew Weaver<br>Director of Quality Assurance and Regulatory Affairs<br>Telephone: (801) 553-9991<br>Facsimile: (801) 553-9993<br>Email: DWeaver@orthodevelopment.com | | DATE PREPARED: | July 31, 2015 | | PROPRIETARY<br>NAME: | Balanced Knee® System TriMax™ CR Femoral Component<br>and E-Vitalize® CR and UC Tibial Inserts | | COMMON NAME: | Total Knee Replacement Prosthesis | | CLASSIFICATION: | Class II Device | | PRODUCT<br>CODES/<br>REGULATION<br>DESCRIPTION<br>AND NUMBER: | JWH - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis (21 CFR 888.3560)<br>OIY - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis (21 CFR 888.3560) | | PREDICATE<br>DEVICES: | Balanced Knee® System (K994370),<br>Ortho Development Corporation<br>Balanced Knee® System Ultracongruent Tibial Insert (K090705),<br>Ortho Development Corporation<br>Balanced Knee® System High Flex PS (K123457),<br>Ortho Development Corporation<br>Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella (K131337)<br>Ortho Development Corporation | {4}------------------------------------------------ ### Device Description The Balanced Knee® System TriMax™ CR femoral component is a highly polished Co-Cr-Mo cruciate retaining femoral component that is designed to accommodate increased range of motion up to 150° of flexion. E-Vitalize® CR and UC tibial inserts are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE (same material as K131337). All components are single use only and the TriMax™ CR femoral component is intended for cemented use only. The E-Vitalize® CR and UC tibial inserts may be used with TriMax™ CR or BKS CR femoral components. E-Vitalize® CR and UC tibial inserts may also be used with all Ortho Development's tibial tray component offerings. The TriMax™ CR femoral component may be used with all Ortho Development patella component offerings. #### Intended Use The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications: - 1. Loss of knee joint configuration and joint function. - 2. Osteoarthritis of the knee joint. - 3. Rheumatoid arthritis of the knee joint. - 4. Post-traumatic arthritis of the knee joint. - 5. Valgus, varus, or flexion deformities of the knee joint. - 6. Revision procedures where other treatments or devices have failed. #### Technological Characteristics The predicate devices and TriMax™ CR femoral component and E-Vitalize® CR and UC tibial inserts are based on the following same technological elements: TriMax™ CR Femoral Component - Cruciate retaining femoral component design - Increased range of motion up to 150° flexion - Cemented fixation of femoral component onto prepared distal femur 0 - Available in a range of sizes to accommodate patient anatomy - Material: Co-Cr-Mo ASTM F75-12 #### E-Vitalize® CR Tibial Insert - Cruciate retaining bearing surface design - Available in a range of sizes and thicknesses to accommodate patient anatomy - Use of a locking mechanism to secure tibial insert to tibial tray ● - Material: Extensively Crosslinked Vitamin E Polyethylene UHMWPE (α-tocopherol) ASTM F2695-12 {5}------------------------------------------------ #### E-Vitalize® UC Tibial Insert - Ultracongruent bearing surface design - Available in a range of sizes and thicknesses to accommodate patient anatomy - Use of a locking mechanism to secure tibial insert to tibial tray - Material: Extensively Crosslinked Vitamin E Polyethylene UHMWPE (α-tocopherol) ASTM F2695-12 (same material as K131337) ### Performance Data The following non-clinical evaluations were performed and demonstrated substantial equivalence to the predicate devices: Range of Motion, Femorotibial Constraint, Femorotibial Contact Area, Patellofemoral Constraint, Patellofemoral Contact Area, Femoral Component Fatigue Strength, Insert Assembly/Disassembly, and Knee Wear. ### Basis for Substantial Equivalence The TriMax™ CR femoral component and E-Vitalize® CR and UC tibial inserts are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.