(60 days)
No
The 510(k) summary describes a physical knee implant with different sizes and coatings. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties and biocompatibility.
Yes
The device is a knee implant intended to alleviate severe pain, correct deformities, and improve mobility due to various knee conditions, which are therapeutic functions.
No
The device is a knee implant intended for treating severe knee joint pain, loss of mobility, and disability by replacing damaged joint components. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines 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 the physical and mechanical properties of these components. There is no mention of software as the primary or sole component of the device.
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 described as a physical implant (femoral and tibial components) made of metal alloys. IVDs are typically reagents, kits, or instruments used to test samples from the human body (like blood, urine, or tissue) in vitro (outside the body).
- Performance Studies: The performance studies focus on the mechanical properties, coating characteristics, and biocompatibility of the implant, which are relevant for a surgical device. They do not involve testing biological samples for diagnostic purposes.
Therefore, the Opulent TiNbN Coated Knee is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Opulent 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 join contcularly 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 Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
Product codes
JWH
Device Description
The Opulent 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.
5.7.1 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.
5.7.2 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 was subjected to following non clinical performance testing to evaluate device function and mechanical performance.
- a) Coating characteristics of TiNbN Coating
- o Coating thickness
- Coating hardness о
- Coating roughness O
- O Coating adhesion strength
- Colour (visual inspection) o
- b) Coating chemical composition and SEM EDS
- c) Wear resistance
5.11 Summary of Biocompatibility testing
- Cytotoxicity test ISO 10993-5 .
- . Skin Sensitization study ISO 10993-10
- Acute irritation/Intracutaneous reactivity test ISO 10993-10 ●
- Acute systemic toxicity study ISO 10993-11 ●
- Material mediated Pyrogenicity ISO 10993-11, USP General Chapter ●
- Sub-chronic systemic toxicity test ISO 10993-11 .
- Bone Implantation Study ISO 10993-6 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
November 18, 2022
Meril Healthcare Pvt. Ltd. Neelam Desai Senior Manager- Regulatory Affairs Survey No. 135/2/B & 174/2, H1-H3, Meril Park Muktanand Marg, Chala Vapi. Gujarat 396191 INDIA
Re: K222816
Trade/Device Name: Opulent 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: September 11, 2022 Received: September 19, 2022
Dear Neelam Desai:
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 -S
Ting Song, 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
2
Indications for Use
510(k) Number (if known) K222816
Device Name Opulent TiNbN Coated Knee
Indications for Use (Describe)
The Opulent 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 join contcularly 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 Opulent 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)
X 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/1 description: The image shows the word "Meril" in white font against a blue background. There are two dots above the "i" in "Meril", one yellow and one white. The font is sans-serif and appears to be a company logo.
5. 510(k) SUMMARY
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.
Applicant: 5.1
Meril Healthcare Private Limited Ground & First Floor, Survey No.173/4 & First Floor H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA
Primary Contact Person: 5.2
Neelam Desai Senior Manager- Regulatory Affairs E mail: neelam.desai@merillife.com Cell: +91 9054623695
5.3 Secondary Contact Person:
Gayathri Nair
Deputy General Manager - Regulatory Affairs/ Quality Assurance E mail: gayathri.nair@merillife.com Cell: +91 9909033393
Date prepared: September 11th, 2022 5.4
Device information: ર્ડ
| Proprietary Name: | Opulent TiNbN Coated Knee |
|---|---|
| Common / Usual Name: | Total Knee prosthesis |
| Classification name: | Knee joint femorotibial metal/polymer semi-constrained |
| cemented prosthesis | |
| Regulation Number: | 21 CFR 888.3560 |
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Image /page/4/Picture/1 description: The image shows the word "Meril" in white font on a blue background. There is a yellow dot above the "i" in "Meril". The font is sans-serif and appears to be a company logo.
| Product Code: | JWH |
|---|---|
| --------------- | ----- |
Device Class: Class II
Predicate Device 5.6
| Subject device | Equivalent
device category | Manufacturer | Trade name | 510(k) number |
|------------------------------|-------------------------------|----------------------------------|------------------------------|---------------|
| Opulent TiNbN
Coated Knee | Predicate device | Meril
Healthcare Pvt.
Ltd. | Opulent TiNbN
Coated Knee | K212839 |
5.7 Device Description:
The Opulent 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.
5.7.1 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.
5.7.2 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.
5.8 Indication for use:
The Opulent 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.
5
Meri
- . 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 Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
5.9 Comparison of technological characteristics:
The subject device is substantially equivalent to FDA cleared Opulent TiNbN Coated Knee (K212839) from Meril Healthcare Pvt. Ltd. Both have same intended use, manufacturing process, device design/technological characteristics, materials, packaging and sterilization method. There is no technological difference between the subject device and the predicate device.
5.10 Non clinical Performance data:
The subject device was subjected to following non clinical performance testing to evaluate device function and mechanical performance.
- a) Coating characteristics of TiNbN Coating
- o Coating thickness
- Coating hardness о
- Coating roughness O
- O Coating adhesion strength
- Colour (visual inspection) o
- b) Coating chemical composition and SEM EDS
- c) Wear resistance
5.11 Summary of Biocompatibility testing
- Cytotoxicity test ISO 10993-5 .
- . Skin Sensitization study ISO 10993-10
- Acute irritation/Intracutaneous reactivity test ISO 10993-10 ●
- Acute systemic toxicity study ISO 10993-11 ●
6
Image /page/6/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The word is white and is set against a light blue background. There are two small yellow dots above the "i" in "Meril", which serve as the dot for the "i".
- Material mediated Pyrogenicity ISO 10993-11, USP General Chapter ●
- Sub-chronic systemic toxicity test ISO 10993-11 .
- Bone Implantation Study ISO 10993-6 .
5.12 Conclusion
Based on performance testing results and similarities in intended use, manufacturing process, device design/technological characteristics, packaging and sterilization method, the subject device is considered substantially equivalent to the previously cleared predicate device.