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 and Primary PCK Components only).
The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

Device Description

The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically the Freedom® Total Knee System - Porous Tibial Base Plate. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria and performance analysis. Therefore, the information requested about acceptance criteria and a study proving the device meets them, typically found in a clinical trial report or a performance study for novel devices or software, is not directly applicable in the same way.

However, I can extract the information related to the non-clinical performance testing conducted to support the substantial equivalence claim. This testing serves as the "study" demonstrating that the device performs as intended and is similar to the predicate.

Here's an interpretation based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" for each test in the way a clinical trial might. Instead, the "acceptance" is implicitly defined by demonstrating that the subject device's performance is substantially equivalent to established performance standards or the predicate/reference devices. The "reported device performance" is summarized as the satisfactory completion of these tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Tibial Tray Fatigue: Device must withstand fatigue loading per ASTM F1800.	All necessary testing performed. (Implies satisfactory performance meeting the standard).
Residual Particle Characterization: Device must meet acceptable levels of residual particles per ASTM F1877, comparable to literature.	Results were shown to be substantially equivalent to values presented in the literature for the reference device (K030623).
Porous Surface Characterization: Porous structure must meet specifications for various characteristics per ASTM F1854, F1160, F1044, F1978, F1147.	All necessary testing performed. (Implies satisfactory performance meeting the standards).
Sterilization: Device must achieve a sterility assurance level (SAL) of 10^-6 per ISO 11137-2.	Sterilization per ISO 11137-2. (Implies successful sterilization to the required SAL).
Endotoxin: Device must meet acceptable endotoxin levels per AAMI ST72.	Endotoxin per AAMI ST72. (Implies acceptable endotoxin levels).
Biocompatibility: Device materials must be biocompatible per ISO 10993-1, ISO 10993-5.	Biocompatibility per ISO 10993-1, ISO 10993-5. (Implies successful demonstration of biocompatibility).
Modular Disassembly: If applicable, modular components must meet disassembly force requirements (leveraged from reference device).	Modular disassembly testing was leveraged from the reference device (K090411) as the subject device uses an identical tibial insert locking mechanism. (Implies that the design similarity ensures equivalent performance without new testing).

2. Sample sized used for the test set and the data provenance

Sample Size: The document does not specify the exact number of implants or test coupons used for each non-clinical test (e.g., how many tibial trays were fatigue tested). It mentions that "All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards."
Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human clinical data. Thus, terms like "country of origin" or "retrospective/prospective" are not applicable. The data originates from laboratory testing conducted by or for the manufacturer (Maxx Orthopedics, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The "test set" here refers to physical specimens (implants/coupons) for non-clinical testing, not patient data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and requirements of the referenced ASTM and ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the tests are non-clinical, mechanical, and material evaluations performed against established standards, not clinical data requiring adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical knee implant, not an AI software or diagnostic tool used by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical knee implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced ASTM and ISO standards. For example, the acceptable number of cycles for fatigue testing is defined by ASTM F1800. For residual particles, the "ground truth" is the acceptable range established in the literature for the reference device, as evaluated against ASTM F1877.

8. The sample size for the training set

This is not applicable. The device is a physical knee implant. There is no "training set" in the context of machine learning or AI. The manufacturing process is validated, and the device's design is based on engineering principles and existing predicate designs, not a data-driven training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

Summary

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February 13, 2025

Maxx Orthopedics, Inc. % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock, Georgia 30188

Re: K241597

Trade/Device Name: Freedom® Total Knee System - Porous Tibial Base Plate Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: January 17, 2025 Received: January 17, 2025

Dear Justin Gracyalny:

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/cdrb/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.

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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 System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); 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 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory

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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,

Image /page/2/Picture/3 description: The image shows the name "Lixin Liu-S" in a large, sans-serif font. The text is black and appears to be the main focus of the image. The background is white, with a faint, light blue watermark-like design that is partially visible behind the text.

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

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Indications for Use

Submission Number (if known)

K241597

Device Name

Freedom® Total Knee System - Porous Tibial Base Plate

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 valqus, 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 and Primary PCK Components only).

The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Counter Use (21 CFR 801 Subpart C)

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K241597

Freedom® Total Knee System – Porous Tibial Base Plate

Date Prepared	February 13, 2025
Sponsor	Maxx Orthopedics Inc.2460 General Armistead Ave, Suite 100Norristown, PA 19403
510(k) Contact	Secure BioMed EvaluationsJustin Gracyalny, MSE7828 Hickory Flat Highway, Suite 120Woodstock, GA 30188Phone: 770-837-2681Email: Regulatory@SecureBME.com
Trade Name	Freedom® Total Knee System – Porous Tibial Base Plate
Common Name	Knee Prosthesis
Product Code -RegulationNumber	MBH - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR §888.3565) JWH – Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3560)
PrimaryPredicate	K182346 Exactech, Inc. TRULIANT Porous Tibial Tray
ReferenceDevice(s)	K030623 Smith & Nephew Profix TKA SystemK090411 Maxx Orthopedics Inc. Freedom Metal Backed Tibial ComponentK171991 DJO Surgical, Inc. EMPOWR Porous Knee SystemK211221 Smith & Nephew, Inc. Porous Patella and Porous Tibia BaseplateK230321 Zimmer, Inc. Persona™ Personalized Knee System
DeviceDescription	The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.

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Indications forUse Statement	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 ispatellofemoral 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 integrityare present (For PCK Components and Primary PCK Componentsonly).
	The Freedom® Porous Tibial Base Plate and Cementless FemoralComponents are indicated for Cemented or Uncemented use. All othercomponents are indicated for cemented use only.

Comparison of Technological Characteristics

DeviceCharacteristic	Subject DeviceMaxx Orthopedics Inc.Freedom® Total Knee System –Porous Tibial Base Plate	Primary Predicate DeviceExactech, Inc.TRULIANT Porous Tibial TrayK182346
Intended Use	Total Knee Arthroplasty	Total Knee Arthroplasty
Manufacturing	Additive (EBM) and Subtractive	Additive (EBM)
Material	Ti-6Al-4V ELI per ASTM F3001	Ti-6Al-4V per ASTM F2924 /ASTM F136
Porous Coating	Yes	Yes
Base PlateSymmetry	Asymmetrical	Symmetrical
Sterilization	Implants: Provided sterile, SAL 10-6Instruments: Provided non-sterilefor end-user sterilization, SAL 10-6	Implants: Provided sterile, SAL 10-6Instruments: Provided non-sterilefor end-user sterilization, SAL 10-6
Packaging	Dual Tray Configuration	Dual Tray Configuration
Single Use Only	Yes	Yes
Prescription UseOnly	Yes	Yes

Technological Characteristics

There are no significant technological differences between the subject and predicate device. The subject device uses similar materials, is a similar design, and achieves its intended use in an identical manner as the predicate and both devices are manufactured using similar additive manufacturing techniques. Minor differences in base plate geometry, symmetry, and sizing are addressed via performance testing and similarity to the reference devices (K171991, K211221, K230321). Minor differences in the indications for use do not introduce a new intended use when

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compared to the predicate device or impact the safety and effectiveness of the device when used as labeled.

Non-Clinical Performance Testing Summary

All necessary testing has been performed for the subject device to assure substantial equivalence to the predicate device and to demonstrate the subject device performs as intended. All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards. The following evaluations were conducted:

Tibial Tray Fatigue Testing per ASTM F1800
Residual Particle Characterization Testing per ASTM F1877
Porous Surface Characterization Testing per ASTM F1854, ASTM F1160, ASTM F1044, ● ASTM F1978, ASTM F1147
Sterilization per ISO 11137-2 ●
Endotoxin per AAMI ST72 ●
Biocompatibility per ISO 10993-1, ISO 10993-5

Results of the residual particle characterization were shown to be substantially equivalent to values presented in the literature for the reference device (K030623). Modular disassembly testing was leveraged from the reference device (K090411) as the subject device uses an identical tibial insert locking mechanism.

Conclusions

Based on the similarities of the intended use / indications for use, technological and functional characteristics, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.