(226 days)
No
The description focuses on the materials, design, and mechanical testing of a knee implant, with no mention of AI or ML capabilities.
Yes.
The device is a knee implant designed to treat conditions causing severe knee pain, loss of mobility, and functional deformities, thus providing therapeutic benefits to the patient.
No
The device is a knee implant designed for surgical replacement of the knee joint in patients with severe knee pain and disability. It is not used for diagnosis.
No
The device description clearly states that the device is comprised of physical components (Femoral Component and Tibial Component) made of materials like Cobalt-Chromium-Molybdenum and coated with Titanium Niobium Nitride. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant (femoral and tibial components) designed to be surgically placed within the body. IVDs are typically reagents, instruments, or systems used to examine specimens taken from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical properties, wear resistance, and coating characteristics, which are relevant to the function and durability of a surgical implant. IVD performance studies would focus on analytical and clinical performance related to the diagnostic information provided.
Therefore, the Freedom® - TiNbN Coated Knee is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ●
- Tibial Tray Locking Mechanisms Testing ●
- Finite Element Analysis of Tibial Tray
- Tibial base plate component fatigue testing
- . Tibial Post Fatigue Strength (static and fatigue)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K082019(Femoral PS Component), K090411(Tibial Base Plate), K091280( Femoral CR Component)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| Residential Use (Per Ch. 655, Salem Revised Code) |
|---|
| Care-Taker Quarters (Per Ch. 655, Salem Revised Code) |
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: priscilla.herpai@maxxortho.com Phone: +484-342-0092 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: +91 9909033393
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
device | Equivalent
device category | Manufacturer | Trade name | 510(k) |
|---------------------------------------|-------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Freedom®
- TiNbN
Coated
Knee | Predicate device | Maxx
Orthopedics
Inc., USA | Freedom® Total
Knee System | K082019(Femoral
PS Component),
K090411(Tibial
Base Plate),
K091280( Femoral
CR Component) |
| | Reference
device | DJO Surgical
(Encore
Medical, L.P.),
USA | Foundation® Knee
System with
TiNbN coating,
Foundation® PS
Knee System with
TiNbN coating, 3D
Knee™ System
with TiNbN
coating | K122239 |
| | | Waldemar Link
GmbH & Co.
KG, Germany | LINK® Gemini®
SL® Total Knee
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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Image /page/5/Picture/0 description: The image is a 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.
(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
6
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.