Freedom Total Knee System (E-Poly Tibial Liners)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION August 7, 2026 Maxx Orthopedics, Inc. Asawari Hare Regulatory Associate 2460 General Armistead Ave. #100 Norristown, Pennsylvania 19403 Re: K261563 Trade/Device Name: Freedom Total Knee System (E-Poly Tibial Liners) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH, OIY Dated: May 11, 2026 Received: May 11, 2026 Dear Asawari Hare: 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} K261563 - Asawari Hare 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} K261563 - Asawari Hare 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, Peter G. Allen -S Digitally signed by Peter G. Allen -S Date: 2026.08.07 10:00:58 -04'00' for Lixin Liu, PhD 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) K261563 Device Name Freedom Total Knee System (E-Poly Tibial Liners) Indications for Use (Describe) The Freedom®Total Knee System is indicated for the following: - Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Correction of functional deformities. - Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy. - Moderate valgus, varus, or flexion trauma. - Knee fractures untreatable by other methods. - Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components, Primary PCK Components, and Metaphyseal Cones only). The Freedom Porous Tibial Base Plate, Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only. The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction. 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} K261563 (Page 1 of 3) 510(k) #: # 510(k) Summary Prepared on: 2026-07-30 Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Maxx Orthopedics, Inc. | | --- | --- | | Applicant Address | 2460 General Armistead Ave #100 Norristown PA 19403 United States | | Applicant Contact Telephone | 6177087388 | | Applicant Contact | Ms. Asawari Hare | | Applicant Contact Email | asawari.hare@maxxortho.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | Freedom Total Knee System (E-Poly Tibial Liners) | | --- | --- | | Common Name | Total Knee Replacement System (with modified tibial liners) | | Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | | Regulation Number | 888.3560 | | Product Code(s) | JWH, OIY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K250382 | Freedom Total Knee System: All-Poly Tibial Plate | JWH | | K082019 | Freedom All-poly Tibial Baseplate | JWH | | K090411 | Freedom Metal Tibial baseplate | JWH | | K182574 | Freedom UC Tibial Liner | JWH | | K243277 | Freedom MC Tibial Liner | JWH | Legally Marketed Reference Devices | K192989 | Libertas E-XLPE Modular Liners | OQI | | --- | --- | --- | Device Description Summary 21 CFR 807.92(a)(4) The E-Poly Tibial implants have been developed with the desire to expand upon the already clinically successful Freedom® Total Knee System by introducing a crosslinked material. The implants will retain the exact design features and geometries of the All-Poly Tibial implant system (K082019, K250382) and the modular, metal-backed systems (K090411, K182574, K243277). By introducing Vitamin E crosslinks into the material, this removes excess radicals in the polymer that contributes to oxidation. These versions will be manufactured from GUR 1020-E UHMPE containing 0.1% Vitamin E. The new Tibial implants are designed to work the same as the existing All-Poly and modular, metal-backed Freedom® system components with identical profiles and size ranges. The E-Poly Tibial implants will come in multiple articular surface types. The Cruciate-Retaining articular surface is identical to those cleared in K082019, the Posterior-Stabilized articular surface is identical to those cleared in {5} K261563 (Page 2 of 3) K082019, the Ultracongruent articular surface is identical to those cleared in K182574, and the Medial Congruent articular surface is identical to those cleared in K243277. This will provide the surgeons with the full portfolio of Freedom® bearing surfaces with a higher wear resistance. Surgeons will be able to use the same instruments/surgical technique to the Freedom® Total Knee System. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) The Freedom® Total Knee System is indicated for the following: - Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Correction of functional deformities. - Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy. - Moderate valgus, varus, or flexion trauma. - Knee fractures untreatable by other methods. - Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components, Primary PCK Components, and Metaphyseal Cones only). The Freedom Porous Tibial Base Plate, Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only. The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction. ## Indications for Use Comparison 21 CFR 807.92(a)(5) Indications for use are the same. ## Technological Comparison 21 CFR 807.92(a)(6) The E-Poly Tibial implants have been developed with the desire to expand upon the already clinically successful Freedom® Total Knee System by introducing a Vitamin E crosslinked material. The implants will retain the exact design features and geometries of the All-Poly Tibial implant system (K082019, K250382) and the modular, metal-backed systems (K090411, K182574, K243277). The implants will be manufactured in GUR 1020-E UHMPE containing 0.1% Vitamin E; this is equivalent to the material in reference device K192989 for the Libertas E-XPLE Modular Liners. This combination will maintain the previous design outputs of the Freedom Knee System while eliminating the oxidation causing radical in the GUR 1020. The new Tibial implants are designed the same as the existing All-Poly and modular, metal-backed Freedom® system components with identical profiles, size ranges, and articular surface types. The Cruciate-Retaining articular surface is identical to those cleared in K082019, the Posterior-Stabilized articular surface is identical to those cleared in K082019, the Ultracongruent articular surface is identical to those cleared in K182574, and the Medial Congruent articular surface is identical to those cleared in K243277. This will provide the surgeons with the full portfolio of Freedom® bearing surfaces. Surgeons will be able to use the same instruments/surgical technique to the Freedom® Total Knee System. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Range of Motion (ROM) analysis was completed separately for the Cruciate Retaining (CR), Posterior Stabilizing (PS), Medial Congruent (MC), and Ultra Congruent (UC) systems in previous submissions. Implant geometry is the only driving factor in range of motion, therefore change in material was not considered in performance and no new ROM testing was required. Reference documentation for ROM on the CR, PS, and UC was used. In prior submissions, it was determined that the MC articulating surface does not create a new worst case and was therefore validated through the UC surface testing. Contact pressure/stress analysis was completed separately for the CR, PS, MC, and UC systems in previous submission. Implant geometry is the only driving factor in contact pressure, therefore change in material was not considered in performance and no new contact pressure/stress testing was required. For wear resistance, implant geometry and material are considered as the driving factors. As implant geometry was proven to be identical to the previously approved Freedom Knee System, material was taken as the primary consideration in wear resistance. Wear testing was, previously, completed on the E-Poly Metal backed PS implant (following ISO 14243-1:2009 and 14243-2:2009). To evaluate material change, the PS E-Poly Implant was reported on in 838-150918-20-657 under the same standard. These tests primarily looked at mean wear rate (mg/million cycles) and wear. In comparison, the E-Poly PS Tibias showed lower wear rates and wear. As material was the isolated difference between the two reports, the comparison can be extrapolated to all other articulating surfaces. {6} K261563 (Page 3 of 3) The E-Poly Tibial Implants were determined to be within the scope of the reference Range of Motion Validations completed on the Freedom Knee CR, PS, UC, and MC implant families. The E-Poly Tibial Implants were determined to be within the scope of the referenced Contact Pressure and Stress Validation completed on the Freedom Knee CR, PS, UC, and MC implant families. Due to a comparison between the approved PS system wear testing and the E-Poly PS wear testing, it was determined that the E-Poly Implants do not create a new worst case for wear resistance. Therefore, they fall within the scope of the wear resistance validations completed on the Freedom Knee System. All E-Poly Tibial Implant were found to be substantially equivalent to the previously validated implants and are thus verified and validated for clinical use.