(65 days)
Not Found
No
The 510(k) summary describes a traditional knee replacement system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical testing and sterility, not algorithmic performance.
Yes
This device is a total knee system intended to replace joint surfaces due to severe knee pain and disability from various conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The Destiknee™ Total Knee System is described as a system of components intended to replace parts of the knee joint due to various conditions. It undergoes mechanical performance testing and sterility testing. It does not perform any diagnostic function.
No
The device description clearly states it is a system of components intended to replace knee joint surfaces, manufactured from metallic and non-metallic materials, indicating it is a physical implant, not software.
Based on the provided information, the Destiknee™ Total Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a total knee system for replacing knee joint surfaces in patients with severe knee pain and disability due to various conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details components intended to replace parts of the knee joint, made from metallic and non-metallic materials. This aligns with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Destiknee™ Total Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DestikneeTM Total Knee System is indicated for patients with severe knee pain and disability due to:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, 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.
The Destiknee™ Total Knee System 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 Destiknee™ Total Knee System is a system of components intended to replace the Femoral, Tibial and Patella articular surfaces of the knee joint. The components are available in many styles and sizes and are manufactured from metallic and non-metallic materials.
The Destiknee TM Total Knee System was originally cleared under 510(k): K160771. The purpose of current submission is to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System.
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 components of Destiknee™ Total Knee System were subjected to following nonclinical performance testing to evaluate device function/ mechanical performance.
- Fatigue test of Tibial Base Plate (ASTM F1800-12; ISO 14879-1:2000) ●
Endotoxin testing has demonstrated that the manufacturing process does not introduce Endotoxin as a bi-product of the manufacturing and cleaning process.
Destiknee™ Total Knee System is subjected to 14 day USP sterility testing and USP Endotoxin testing prior to release.
Meril Healthcare Pvt. Ltd. Confirms that the Bacterial Endotoxin Test [(BET)/LAL test] will be conducted on final sterilized device of every batch prior to releasing to US market.
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.
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.
Not Found
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.
0
November 30, 2017
Image /page/0/Picture/1 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Meril Healthcare Pvt. Ltd. % Linda Braddon President & Chief Executive Officer Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K172936
Trade/Device Name: Destiknee™ Total Knee System 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 27, 2017 Received: October 04, 2017
Dear Linda Braddon:
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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson -S
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)
K172936
Device Name DestikneeTM Total Knee System
Indications for Use (Describe)
The DestikneeTM Total Knee System is indicated for patients with severe knee pain and disability due to:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, 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.
The Destiknee™ Total Knee System is intended for cemented use only. This device is for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
5.1 Applicant:
Meril Healthcare Private Limited Survey No. 135/2/B & 174/2, First Floor, H1-H3, Meril Park Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA
5.2 Regulatory Correspondent:
Linda Braddon, Ph.D President and CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA, 30188 Email: lgb@securebme.com Phone: +-770-837-2681
Meril Healthcare Contact Information:
Bhavik Gondaliya Manager- regulatory Affairs Meril Healthcare Private Limited Survey No. 135/2/B & 174/2, First Floor, H1-H3, Meril Park, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA Mobile: +91 – 9687604713 Fax: +91 260-3052125 E mail: Bhavik.gondaliya@merillife.com
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| 5.3 | Date prepared: | 27, September 2017 |
|---|---|---|
| 5.4 | Device information: | |
| Proprietary Name: | DestikneeTM Total Knee System | |
| Common / Usual Name: | Total Knee Replacement | |
| Regulation name: | Knee joint patellofemorotibial | |
| polymer/metal/polymer semi-constrained cemented | ||
| prosthesis per 21 CFR 888.3560 | ||
| Product Code: | JWH | |
| Device Class: | Class II |
5.5 Predicate Devices
| Component | Predicate
Device | Manufacturer | Submission
Number |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------|------------------------------|
| Femoral Component,
Tibial Component (Tibial Base
Plate and Tibial Articular
Surface), All Poly Tibial
Component, All Poly Patella | DestikneeTM
Total Knee
System | Meril Healthcare
Pvt. Ltd. | 510(k)
Number:
K160771 |
5.6 Device Description:
The Destiknee™ Total Knee System is a system of components intended to replace the Femoral, Tibial and Patella articular surfaces of the knee joint. The components are
5
available in many styles and sizes and are manufactured from metallic and non-metallic materials.
The Destiknee TM Total Knee System was originally cleared under 510(k): K160771. The purpose of current submission is to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System.
5.7 Indications for Use:
The Destiknee™ Total Knee System is indicated for patients with severe knee pain and disability due to:
- 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.
The Destiknee™ Total Knee System is intended for cemented use only. This device is for single use only.
5.8 Comparison of Technological characteristics:
The Destiknee™ Total Knee system is substantially equivalent to the previously cleared predicate device based on similarities in intended use, device design/technological characteristics, materials and sterilization method.
Non clinical Performance data: 5.9
The components of Destiknee™ Total Knee System were subjected to following nonclinical performance testing to evaluate device function/ mechanical performance.
- Fatigue test of Tibial Base Plate (ASTM F1800-12; ISO 14879-1:2000) ●
6
Endotoxin testing has demonstrated that the manufacturing process does not introduce Endotoxin as a bi-product of the manufacturing and cleaning process.
Destiknee™ Total Knee System is subjected to 14 day USP sterility testing and USP Endotoxin testing prior to release.
Meril Healthcare Pvt. Ltd. Confirms that the Bacterial Endotoxin Test [(BET)/LAL test] will be conducted on final sterilized device of every batch prior to releasing to US market.
5.10 Conclusion
Based on performance testing results and similarities in intended use, device design/technological characteristics, materials and sterilization method, the Destiknee™ Total Knee System is considered substantially equivalent to the previously cleared predicate device.