Destiknee Total Knee System
by Meril Healthcare Private Limited
510(k) K160771
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160771 | Date19 Dec 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Destiknee Total Knee System is a Total Knee Prosthesis (Product Code: JWH) designed for primary total knee arthroplasty. It features modular components for the femoral, tibial, and patellar surfaces, accommodating both cruciate-retaining and posterior-stabilized designs to restore knee function and alignment. The system incorporates high-flexion geometry to enhance range of motion and anatomical fit, addressing common degenerative joint conditions. Its modularity allows customisation to match individual patient anatomy and surgical requirements.
The system is supplied as a sterile, single-use orthopaedic implant intended for surgical use under aseptic conditions. Components are available in multiple sizes to ensure precise fit and stability. Authorised for use in the United States under FDA 510(k) clearance (K160771), the Destiknee Total Knee System adheres to traditional review pathways within the Orthopaedic Devices advisory committee. Storage and handling follow standard orthopaedic implant protocols to maintain sterility and integrity prior to implantation.
Other devices from Meril Healthcare Private Limited
Questions
AI-generated answers, 1 Oct 2026
What is the Destiknee Total Knee System used for?
The Destiknee Total Knee System is designed specifically for primary total knee arthroplasty, meaning it replaces damaged knee joints due to degenerative conditions like osteoarthritis. Its modular components allow surgeons to choose between cruciate-retaining or posterior-stabilized designs, ensuring better alignment and function tailored to individual patient anatomy. The system’s high-flexion geometry also helps restore a wider range of motion, improving mobility for patients.
How is the Destiknee Total Knee System supplied and prepared for surgery?
The system is supplied as a sterile, single-use orthopaedic implant, meaning each component is intended for one surgical procedure only. This ensures sterility and reduces the risk of infection. Components must be handled under aseptic conditions prior to implantation, following standard orthopaedic implant protocols to maintain their integrity and readiness for use.
Are the components reusable or single-use?
The Destiknee Total Knee System is explicitly designed for single-use only. This is a standard practice for orthopaedic implants to prevent contamination and ensure patient safety. Reusing implants could compromise sterility and increase infection risks, which is why single-use protocols are strictly enforced in surgical settings.
What sizes are available for the Destiknee Total Knee System?
The system includes multiple component sizes to accommodate varying patient anatomies and surgical requirements. While exact sizing details are not specified, modularity ensures precise fitting for both femoral, tibial, and patellar surfaces. Surgeons select the appropriate sizes based on preoperative planning and intraoperative assessment to achieve stability and optimal function.
How should the Destiknee Total Knee System be stored before use?
The system must be stored according to standard orthopaedic implant protocols to preserve sterility and structural integrity. This typically involves keeping components in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the implants remain uncontaminated and ready for surgical use when needed.