(273 days)
Not Found
No
The device description focuses on the materials, design, and mechanical properties of a total knee replacement system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total knee system intended to alleviate severe knee pain and disability by replacing damaged parts of the knee joint, which directly addresses a medical condition to improve the patient's health and function.
No
This device is a total knee system, which is a prosthetic implant used to replace damaged knee joint components, not to diagnose a condition.
No
The device description clearly outlines physical components made of metal and plastic, intended for surgical implantation. There is no mention of software as a component of the device itself.
Based on the provided text, the Destiknee™ Total Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Destiknee™ Total Knee System is a surgical implant designed to replace the articulating surfaces of the knee joint. Its intended use is to treat severe knee pain and disability by physically replacing damaged parts of the knee.
The description clearly outlines a mechanical device intended for surgical implantation, not for analyzing biological samples.
N/A
Intended Use / 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.
Product codes
JWH
Device Description
The Destiknee™ Total Knee System consists of following components.
- . Femoral Component
- . Tibial Component which is available in following two designs
- o Metal Backed Tibial Component which consists of Tibial Base Plate and Tibial Articular Surface (viz. Tibial Liner)
- All Poly Tibial Component (viz. All Poly) and o
- All Poly Patella Component .
Each of these components are described below.
-
Femoral Component
Femoral Component is fabricated from Cobalt-Chromium-Molybdenum alloy and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection technique.
The Femoral Component is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).Each design is classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes. -
Tibial Component
Tibial Component is available in following two designs:
- a) Metal Backed (modular/two pieces)
- b) All Poly (non-modular/single piece)
Metal backed design of Tibial component is modular two piece design viz. Tibial Base Plate and Tibial Articular Surface (viz. Tibial Liner).
The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum alloy and is intended for use with the Tibial Liner for cemented application to replace the articulating surface of the proximal tibia in a measured resection.
Tibial Liner is fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for use with the Tibial Base Plate to replace the articulating surface of the proximal tibia in a measured resection. It has a locking mechanism on the peripheral edges of the distal surface to lock into the Tibial Base Plate. The Tibial Liner is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).Each PS and CR designs are available in 14 configurations. Each configuration is further available in four different thickness viz. 9mm, 11mm, 14mm and 17mm.
All poly design is a non modular single piece design viz. All Poly Tibial Component (viz. All Poly)fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. All Poly is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).
Each PS and CR designs are available in 12 configurations. Each configuration is available in five different thickness viz. 9mm, 11mm, 14mm, 17mm and 20mm.
All Poly Patella Component is fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE). It is available in a symmetric single radius design. The symmetrical design is available in 4 diameters.
All materials used in Destiknee™ Total Knee System meet ASTM standards for implants, viz. ASTM F648 "Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants" and ASTM F-75 "Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting alloy for Surgical Implants (UNS R30075)".
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
patients with severe knee pain and disability
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)
All the necessary performance tests to determine the material and mechanical characteristics have been performed on predicate device viz. Freedom® Total Knee System.
Performance testing includes: endurance properties (cyclical testing), stability, surface stress, kinematic range of motion.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Meril Healthcare Private Limited % Jon Ward President and CEO AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, Florida 33572
Re: K160771
Trade/Device Name: Destiknee Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 14, 2016 Received: November 14, 2016
Dear Jon Ward:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K160771
Device Name: Destiknee™- Total Knee System
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.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IFNECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The letters are white against a light blue background. There is a small yellow dot above the "i" in "Meril," which replaces the typical dot.
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 First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA
5.2 Contact Person:
Umesh Sharma Deputy General Manager (DGM) Meril Healthcare Private Limited H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA Phone: +91 - 2603063811 Mobile: +91 - 9904805571 Fax: +91 260-3052125 E mail: umesh.sharma@merillife.com
5.3 Regulatory Correspondent:
Jon Ward President and CEO AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, FL 33572 Phone: 813-645-2855 x104 Fax: 813-645-2856 Email: wardjp(@ajwtech.com
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Image /page/4/Picture/1 description: The image shows the word "Meril" in a sans-serif font on a blue background. The "i" in Meril is dotted with two circles, one yellow and one white. The word is centered in the image and takes up most of the space.
ર્સ્ડ
| 5.4 | Date prepared: |
|---|---|
| ----- | ---------------- |
14Dec2016
| Device information: | |
|---|---|
| Proprietary Name: | Destiknee™ Total Knee System |
| Common / Usual Name: | Total Knee Replacement |
| Regulation name: | Knee joint patellofemorotibial |
| polymer/metal/polymer semi-constrained cemented | |
| prosthesis. | |
| Review Panel | Orthopaedic |
| Regulation Number: | 21 CFR 888.3560 |
| Product Code: | JWH |
| Device Class: | Class II |
5.6 Predicate Device
5.7 Device Description:
The Destiknee™ Total Knee System consists of following components.
- . Femoral Component
- . Tibial Component which is available in following two designs
- o Metal Backed Tibial Component which consists of Tibial Base Plate and Tibial Articular Surface (viz. Tibial Liner)
- All Poly Tibial Component (viz. All Poly) and o
- All Poly Patella Component .
Each of these components are described below.
1. Femoral Component
Femoral Component is fabricated from Cobalt-Chromium-Molybdenum alloy and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection technique.
5
Mer
The Femoral Component is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).Each design is classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes.
2. Tibial Component
Tibial Component is available in following two designs:
- a) Metal Backed (modular/two pieces)
- b) All Poly (non-modular/single piece)
Metal backed design of Tibial component is modular two piece design viz. Tibial Base Plate and Tibial Articular Surface (viz. Tibial Liner).
The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum alloy and is intended for use with the Tibial Liner for cemented application to replace the articulating surface of the proximal tibia in a measured resection.
Tibial Liner is fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for use with the Tibial Base Plate to replace the articulating surface of the proximal tibia in a measured resection. It has a locking mechanism on the peripheral edges of the distal surface to lock into the Tibial Base Plate. The Tibial Liner is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).Each PS and CR designs are available in 14 configurations. Each configuration is further available in four different thickness viz. 9mm, 11mm, 14mm and 17mm.
All poly design is a non modular single piece design viz. All Poly Tibial Component (viz. All Poly)fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. All Poly is available in two designs viz. Posterior Stabilized (PS) and Cruciate Retaining (CR).
Each PS and CR designs are available in 12 configurations. Each configuration is available in five different thickness viz. 9mm, 11mm, 14mm, 17mm and 20mm.
6
All Poly Patella Component is fabricated from industry standard Ultra High Molecular Weight Polyethylene (UHMWPE). It is available in a symmetric single radius design. The symmetrical design is available in 4 diameters.
All materials used in Destiknee™ Total Knee System meet ASTM standards for implants, viz. ASTM F648 "Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants" and ASTM F-75 "Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting alloy for Surgical Implants (UNS R30075)".
5.8 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.
Comparison of Technological characteristics: રું. તે જેવી સાંતર તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખે
The Destiknee™ Total Knee system is identical to the predicate device with respect to intended use, device design, materials, and method of sterilization.
All the necessary performance tests to determine the material and mechanical characteristics have been performed on predicate device viz. Freedom® Total Knee System.
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Image /page/7/Picture/1 description: The image shows the word "Meril" in a sans-serif font against a blue background. The letters are white, except for a small yellow dot above the "i" and a white dot to the right of the yellow dot. The overall design is simple and clean, with a focus on readability and a modern aesthetic.
5.10 Non clinical Performance data:
Destiknee™ Total Knee System is identical to the predicate device viz. Freedom® Total Knee System with respect to intended use, device design, materials, and method of sterilization.
All necessary performance tests to determine the material and mechanical characteristics have been performed on identical device. Performance testing includes: endurance properties (cyclical testing), stability, surface stress, kinematic range of motion.
There have been no adverse event reports associated with the Destiknee™M Total Knee System and no recalls have been initiated.
5.11 Conclusion
The Destiknee™ Total Knee System is identical to predicate device with respect to intended use, device design, materials and method of sterilization. Therefore, Destiknee™ Total Knee System is considered substantially equivalent to the predicate device.