Freedom Ultra-Congruent CR Tibial Liner by Maxx Orthopedics, Inc.

The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. 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, and polyarthritis.
Correction of functional deformities.
Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
Moderate valgus, varus, or flexion trauma.
Knee fractures untreatable by other methods.

The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

Device Description

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the Freedom Ultra-Congruent CR Tibial Liner does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a standard FDA clearance letter confirming that Maxx Orthopedics, Inc. can market the device because it has been determined to be substantially equivalent to a legally marketed predicate device. It details:

The regulatory classification and product code.
The general controls provisions of the Act that apply.
The Indications For Use for the device.

It does not include any technical performance specifications, clinical study results, or statistical analyses that would allow me to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design, as that data is not present in the provided text.

Summary

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January 22, 2019

Maxx Orthopedics, Inc. Priscilla Herpai Regulatory Manager 2460 General Armistead Avenue, Suite 100 Norristown, Pennsylvania 19403

Re: K182574

Trade/Device Name: Freedom Ultra-Congruent CR Tibial Liner Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 21, 2018 Received: December 26, 2018

Dear Ms. Herpai:

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. 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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The name "Peter G. Allen -S" is written on the left side of the image. On the right side, it says "Digitally signed by Peter G. Allen -S" followed by the date "2019.01.22" and the time "18:03:52-05'00'".

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known: K182574

Device Name: Freedom® Ultra-Congruent CR Tibial Liner

Indications For Use:

Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, ● osteoarthritis, traumatic arthritis, and polyarthritis.
Correction of functional deformities. ●
o Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
Moderate valgus, varus, or flexion trauma. ●
Knee fractures untreatable by other methods. ●

The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

Z Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.