Freedom(R) - TiNbN Coated Knee

K200912 · Maxx Orthopedics, Inc. · JWH · Nov 18, 2020 · Orthopedic

Device Facts

• Record ID: K200912
• Device Name: Freedom(R) - TiNbN Coated Knee
• Applicant: Maxx Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Freedom® - TiNbN Coated Knee is indicated for the following: · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis. · Correction of functional deformities. · Post-traumatic loss of knee joint contour, when there is patellofemoral erosion, dysfunction, and/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. The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

Device Story

Freedom® - TiNbN Coated Knee is a semi-constrained cemented total knee prosthesis; consists of femoral and tibial base plate components. Fabricated from Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy; surface treated with Titanium Niobium Nitride (TiNbN) coating. Available in Cruciate Retaining (CR) and Posterior Stabilized (PS) designs; multiple sizes for patient fit. Used by orthopedic surgeons in clinical settings for total knee arthroplasty. TiNbN coating provides surface modification to the predicate Freedom® Total Knee System. Output is a mechanical joint replacement; restores knee function and mobility; reduces pain. Benefits include improved wear resistance and potential reduction in metal ion release compared to uncoated implants.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and mechanical performance data. Testing included wear resistance, coating chemical composition, thickness, hardness, adhesion strength, roughness, and metal ion analysis. Additional mechanical testing (contact stress, constraint, range of motion, fatigue, locking mechanism) was leveraged from predicate Freedom® and Destiknee™ systems, as the TiNbN coating does not affect these mechanical properties.

Technological Characteristics

Materials: Co-Cr-Mo alloy with TiNbN coating. Design: Semi-constrained cemented patellofemoral/tibial prosthesis. Available in CR and PS configurations. Connectivity: None (mechanical implant). Sterilization: Not specified (referenced as changed). Coating manufacturer: DOT GmbH.

Indications for Use

Indicated for patients with severe knee pain, mobility loss, or disability due to rheumatoid, traumatic, or polyarthritis; functional deformities; post-traumatic contour loss with patellofemoral dysfunction/prior patellectomy; moderate valgus, varus, or flexion trauma; or non-treatable knee fractures. Also indicated for revision surgery with sufficient bone/soft tissue. Contraindicated for non-cemented use.

Regulatory Classification

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).

Predicate Devices

• Freedom® Total Knee System (K082019)
• Freedom® Total Knee System (K090411)
• Freedom® Total Knee System (K091280)

Reference Devices

• Foundation® Knee System with TiNbN coating (K122239)
• Foundation® PS Knee System with TiNbN coating (K122239)
• 3D Knee™ System with TiNbN coating (K122239)
• LINK® Gemini® SL® Total Knee System (K182872)
• Destiknee™ Total Knee System (K172936)
• Destiknee™ Total Knee System (K160771)

Submission Summary (Full Text)

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November 18, 2020

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

Re: K200912

Trade/Device Name: Freedom ® - TiNbN Coated Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 13, 2020 Received: November 16, 2020

Dear Priscilla 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) 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 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200912

Device Name Freedom® - TiNbN Coated Knee

### Indications for Use (Describe)

The Freedom® - TiNbN Coated Knee is indicated for the following:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.

· Correction of functional deformities.

· Post-traumatic loss of knee joint contour, when there is patellofemoral erosion, dysfunction, and/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.

The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

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

| <label> <input checked="true" type="checkbox"/> Residential Use (Per Ch. 655, Salem Revised Code) </label> |
|---------------------------------------------------------------------------------------------------------------|
| <label> <input type="checkbox"/> Care-Taker Quarters (Per Ch. 655, Salem Revised Code) </label> |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image is a logo for Maxx Orthopedics. The word "maxx" is written in large, bold, dark blue letters. Underneath the word "maxx" is a thin, curved, orange line. Below the orange line, the word "orthopedics" is written in smaller, dark blue letters.

#### 510(k) SUMMARY 5.

# 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.

### 5.1 Applicant:

Maxx Orthopedics Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403 USA

### 5.2 Contact Person:

Priscilla Herpai Regulatory Manager Maxx Orthopedics E-mail: [e-mail] Phone: [phone] x 507

#### 5.3 Alternate contact Person:

Gayathri Nair Senior Manager- Regulatory Affairs/ Quality Assurance Meril Healthcare Private Limited E mail: gayathri.nair(@merillife.com Cell: [phone]

#### Date prepared: March 17, 2020 5.4

#### Device information: ર્સ્ડ

Proprietary Name: Freedom® - TiNbN Coated Knee

Total Knee prosthesis Common / Usual Name:

Classification name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulation Number: 21 CFR 888.3560

Product Code: JWH

Device Class: Class II

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Image /page/4/Picture/0 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is written in large, bold, dark blue letters. Below the word "maxx" is a thin, curved, orange line. Below the orange line, the word "orthopedics" is written in smaller, dark blue letters.

#### Predicate Devices 5.6

| Subject<br>device | Equivalent<br>device category | Manufacturer | Trade name | 510(k) |
|---------------------------------------|-------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Freedom®<br>- TiNbN<br>Coated<br>Knee | Predicate device | Maxx<br>Orthopedics<br>Inc., USA | Freedom® Total<br>Knee System | K082019(Femoral<br>PS Component),<br>K090411(Tibial<br>Base Plate),<br>K091280( Femoral<br>CR Component) |
| | Reference<br>device | DJO Surgical<br>(Encore<br>Medical, L.P.),<br>USA | Foundation® Knee<br>System with<br>TiNbN coating,<br>Foundation® PS<br>Knee System with<br>TiNbN coating, 3D<br>Knee™ System<br>with TiNbN<br>coating | K122239 |
| | | Waldemar Link<br>GmbH & Co.<br>KG, Germany | LINK® Gemini®<br>SL® Total Knee<br>System | K182872 |

### 5.7 Device Description:

The Freedom® - TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below,

- Femoral Knee Component CR and PS (Left and Right)
- Tibial Component (Tibial Base Plate)

Each of these components is described below.

# Femoral Component

The femoral Component is fabricated from Cobalt-Chromium-Molybdenum (Co-Cr-Mo), coated with Titanium Niobium Nitride (TiNbN). The Femoral Component is available in two designs: Cruciate Retaining (CR) and Posterior Stabilized (PS). Each of these designs is further classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes (A to H) based on Anterior/Posterior

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(A/P) and Medial/Lateral (M/L) dimensions. Thus a total of thirty two (32) models are available for the Femoral Component.

## Tibial Component (Tibial Base Plate)

The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum coated with TiNbN. The tibial base plate is available in eight different sizes from 1 to 8 based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

#### Indication for use: 5.8

The Freedom® - TiNbN Coated Knee 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. ●
- Revision surgery where sufficient bone and soft tissue integrity are present. .

The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

#### Comparison of technological characteristics: 5.9

The Freedom® - TiNbN Coated Knee with TiNbN coating is substantially equivalent to the Freedom® Total Knee System (K082019- Femoral Component PS; K091280- Femoral Component CR: and K090411- Tibial Base Plate), in that both have the same indications, design, materials, packaging, surgical implantation technique, and intended use. The presence of TiNbN coating and the sterilization method are the only changes to the previously cleared Freedom® Total Knee Systems. These minor technological differences between the subject device and predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the Freedom® - TiNbN Coated Knee is as safe and effective as the Freedom® Total Knee System. Furthermore, the subject device is also substantially

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equivalent to the commercially available devices: Foundation PS Knee System with TiNbN coating; Foundation Knee System with TiNbN coating; 3D Knee System with TiNbN coating (K122239) and LINK® Gemini® SL® Total Knee System (K182872) in that the subject and commercially available devices have the same CoCr Alloy base material, TiNbN coating, Coating manufacturer (DOT GmbH with same specification), and sterilization method.

# 5.10 Non clinical Performance data:

The subject device, Freedom® - TiNbN Coated Knee, as well as representative samples with the TiNbN Coating, were subjected to the following mechanical tests to evaluate device function and performance of the coating for its intended use:

- a) Wear Resistance
- b) Coating Chemical Composition
- c) Coating Thickness
- d) Coating Hardness
- e) Coating Adhesion Strength
- f) Roughness
- g) Metal Ion Analysis

The tests 'b' through 'g' listed above were performed by DOT, GmbH on the representative samples with the TiNbN coating.

Additionally, the below listed tests are leveraged from the testing performed on Freedom® Total Knee System (K082019 Femoral Component (PS), K090411 Tibial Base Plate Component, and K091280 Femoral Component (CR)) and *Destiknee™ Total Knee System (K172936 and K160771). The cleared devices are identical to the subject devices, except that the subject devices have a TiNbN coating on the surface. However, the TiNbN coating does not have any effect on these tests. Therefore, the testing performed on the cleared uncoated Freedom® and Destiknee™ devices can be leveraged for the subjected devices.

- Tibial-Femoral Contact Area Stress and Surface Stress Testing .
- Tibial-Femoral Constraint Testing .
- Range of motion analysis .
- . Patello-Femoral Lateral Subluxation
- Patello-Femoral Contact Area Stress and Surface Stress Testing ●

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Image /page/7/Picture/0 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is written in large, bold, dark blue letters. Below the word "maxx" is a thin, curved, orange line. Below the orange line, the word "orthopedics" is written in smaller, dark blue letters.

- Tibial Tray Locking Mechanisms Testing ●
- Finite Element Analysis of Tibial Tray
- Tibial base plate component fatigue testing
- . Tibial Post Fatigue Strength (static and fatigue)
- * Maxx Orthopedics, Inc. (Maxx) and Meril Healthcare Pvt. Ltd., India (Meril) have entered into an agreement, under which Meril acts as contract manufacturer and distributor for the Freedom® Total Knee System, which includes the Freedom® TiNbN Coated Knee. Meril is also the designer of the Destiknee™ Total Knee System and their version of the TiNbN coated knee – the Opulent Total Knee System. Maxx has licensed the design for its Freedom® Total Knee System to Meril has used to create the the Destiknee™ and Opulent Total Knee Systems. Therefore, the Freedom® Total Knee System is identical to the Destiknee™ and Opulent Total Knee Systems with respect to intended use, device design, materials, technological characteristics, and method of sterilization. Therefore, all testing on the Destiknee™ and Opulent devices is applicable to the Freedom® devices, and new testing of the Freedom® devices is not necessary.

## 5.11 Conclusion

The indications for use and fundamental scientific technology of the subject devices are identical to the predicate devices. Design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of Freedom® - TiNbN Coated Knee.