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510(k) Data Aggregation
K Number
K160771Device Name
Destiknee Total Knee System
Manufacturer
MERIL HEALTHCARE PRIVATE LIMITED
Date Cleared
2016-12-19
(273 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
MERIL HEALTHCARE PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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.
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)".
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