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510(k) Data Aggregation
K Number
K181146Device Name
ASK System
Manufacturer
Date Cleared
2018-08-03
(94 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
L and K Biomed Corporation Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ASK System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The ASK System is designed for cemented use only.
Device Description
The ASK System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a patellofemorotibial, polymer/metal/ polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray, and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
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