EVOLUTION® AM BIOFOAM® Tibial System

{0}  August 21, 2026 Microport Orthopedics, Inc. Jonas Susaraba Senior Regulatory Affairs Specialist 5677 Airline Rd. Arlington, Tennessee 38002 Re: K253728 Trade/Device Name: Evolution® AM BIOFOAM® Tibial System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: July 21, 2026 Received: July 21, 2026 Dear Jonas Susaraba: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253728 - Jonas Susaraba Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K253728 - Jonas Susaraba Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LIXIN LIU -S Lixin Liu, Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K253728 Device Name EVOLUTION® AM BIOFOAM® Tibial System Indications for Use (Describe) The EVOLUTION® AM BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques The EVOLUTION® AM BIOFOAM® Tibial System is for uncemented use only. The EVOLUTION® AM BIOFOAM® Tibial System can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary knee components or the Evolution® Stemmed CS Femur. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **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 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K253728 Page 1 of 4 [LOGO] MicroPort Orthopedics EVOLUTION® AM BIOFOAM® Tibial System Traditional 510(k) 510(k) Summary ### 510(k) Summary of Safety and Effectiveness In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of EVOLUTION® AM BIOFOAM® Tibial System. | Submitted by: | MicroPort Orthopedics Inc. 5677 Airline Rd, Arlington TN, 38002 USA Phone: 866-872-0211 Fax: 855-446-2247 | | --- | --- | | Date: | August 21, 2026 | | Contact Person: | Jonas Susaraba | | Proprietary Name: | EVOLUTION® AM BIOFOAM® Tibial System | | Common Name: | Total Knee Replacement System | | Classification Name and Reference: | 21 CFR 888.3565 Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prothesis Class II | | Subject Product Code and Panel Code: | Orthopedics/87/MBH | | Primary Predicate Device: | EVOLUTION® BIOFOAM® Tibial System, K152298 | | Secondary Predicate Device: | EVOLUTION® Total Knee Systems – Kinematic Alignment Instrumentation and Technique, K243574 | | Reference Devices: | EVOLUTION® MP Total Knee System, K093552 EVOLUTION® MP Total Knee System, K102380 ADVANCE® Modular Tibial Component, K973524 EVOLUTION® MP CS/CR Porous Femur, K140735 Prime and DYNASTY® Additive Manufacturing Shells, K202705 | {5} K253728 Page 2 of 4 [LOGO] MicroPort Orthopedics EVOLUTION® AM BIOFOAM® Tibial System Traditional 510(k) 510(k) Summary # DEVICE INFORMATION # A. Intended Use/Indications for Use Statement The EVOLUTION® AM BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques The EVOLUTION® AM BIOFOAM® Tibial System is for uncemented use only. The EVOLUTION® AM BIOFOAM® Tibial System can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary knee components or the Evolution® Stemmed CS Femur. {6} K253728 Page 3 of 4 [LOGO] MicroPort Orthopedics EVOLUTION® AM BIOFOAM® Tibial System Traditional 510(k) 510(k) Summary ### B. Device Description The EVOLUTION® AM BIOFOAM® Tibial System is a proximal tibial implant component to be used in total knee arthroplasty and a line extension to the EVOLUTION® product family. It is based on modifications to the predicate EVOLUTION® BIOFOAM® Tibial System (K152298) and is offered with and without screw holes in 11 sizes (1-8, 2+, 6+, and 8+) in left and right versions which are identical to the primary predicate EVOLUTION® BIOFOAM® Tibial System (K152298). Unlike the predicate device which is a two-piece design consisting of a tibial base and a modular keel, the subject tibial system is a single piece design that includes a tibial tray and an integrated keel that has identical geometry to the assembled predicate tibial base and modular keel. Like its primary predicate, the subject device is made from a titanium alloy (Ti6Al4V). In contrast, the subject device utilizes additive manufacturing methods to produce the device. The subject EVOLUTION® AM BIOFOAM® Tibial System has a substantially equivalent design, substrate and coating morphology, material, overall form, lock detail geometry, intended use, implantation methods, component, accessory compatibility, and patient contact type/duration as the predicate device. ### C. Technological Comparison The subject EVOLUTION® AM BIOFOAM® Tibial System is a proximal tibial implant component intended for use in total knee arthroplasty and is a line extension of the EVOLUTION® product family. The subject device is substantially equivalent to the primary predicate EVOLUTION® BIOFOAM® Tibial System (K152298) with respect to intended use, implant sizing and configurations, overall form, articular interface geometry, keel geometry, locking mechanism, fixation spike locations, material composition (Ti-6Al-4V titanium alloy), implantation method, component compatibility, and patient contact type and duration. The subject device differs from the primary predicate in that it utilizes a single-piece construction consisting of a tibial tray with an integrated keel, whereas the predicate device utilizes a two-piece design consisting of a tibial base and modular keel. The geometry of the integrated keel is identical to the geometry of the assembled tibial base and modular keel of the predicate device. In addition, the subject device utilizes additive manufacturing technology during production, whereas the predicate device is manufactured using conventional manufacturing methods. These technological differences do not alter the intended use, implant interfaces, or clinical function of the device. Performance testing and engineering analyses demonstrate that the subject device performs as intended and is substantially equivalent to the predicate device. ### D. Nonclinical Testing The following nonclinical testing was performed to support the performance of the subject device and was used as a basis for the determination of substantial equivalence: - Cantilever Fatigue Testing per ASTM F1800 {7} K253728 Page 4 of 4 [LOGO] MicroPort Orthopedics EVOLUTION® AM BIOFOAM® Tibial System Traditional 510(k) 510(k) Summary - Biocompatibility Testing per ISO 10993-1 - Static Tensile Testing per ASTM F1147 - Lap Shear Testing per ASTM F1160 - Compression Testing per ASTM E9 - Abrasion Resistance Testing per ASTM F1978 - Porous coating evaluation according to the FDA guidance, "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, dated April 28, 1994. - Modified surface evaluation per ASTM F1854-09. This standard was used to determine pore diameter, minimum void intercept length, and mean volume percent of voids. - MRI safety evaluation per ASTM F2182-19 and FDA Guidance for "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices. Food and Drug Administration", issued March 2018, ASTM F2182-11a, ASTM F2181-11, ASTM F2052-15, ASTM F2213-17, and ASTM F2119-07 (reapproved 2013).- Biocompatibility testing per ISO 10993-1 (2018), ISO 10993-5 (2009), ISO 10993-10 (2014), ISO 10993-11 (2017), ISO/TS 21726 (2019), and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16th 2016) Previous analysis leveraged for this application due to equivalency include: Lock detail assessment. The nonclinical performance testing results demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate devices. ### E. Clinical Testing Clinical data were not submitted or relied on for a determination of substantial equivalence. ### F. Conclusion The design features, materials information, performance testing and data analysis provided in this premarket notification adequately support the substantial equivalence of the EVOLUTION® AM BIOFOAM® Tibial System with the predicates.