Search Results
Found 1 results
510(k) Data Aggregation
K Number
K231975Device Name
PNK Total Knee System
Manufacturer
Date Cleared
2023-11-21
(141 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
TJC Life Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PNK Total Knee 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 PNK Total Knee System is designed for cemented use only.
Device Description
The PNK Total Knee System is of the fixed bearing type with a posterior stabilized design (PS) and cruciate retained design (CR) configurations. It is a Patellofemorotibial, polymer/metal/polymer. semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial tray component, tibial insert component, and patellar component.
The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.
Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. Total Knee Femoral Component is available in right and left configurations, and eight proportional sizes (sizes 1-8) to accommodate differences in patient anatomy.
The tibial Tray components (tibial baseplate) are made from Ti-6Al-4V titanium alloy, and tibial trays are available in 8 sizes (A-H,) to allow optimal cortical bone coverage of the prepared tibia. The unique stem Diameter for the all 8 sizes.
Tibial Insert components are made from Highly Cross-linked UHMWPE (HXLPE) and are available in 12 proportional sizes that match to corresponding 2 tibial tray components and two femoral components.
Patellar components are made from Highly Cross-linked UHMWPE (HXLPE). The articulating surface of the patellar component is axisymmetric (round) with a flattened sombrero shape and the patella components are available in 6 diameters.
All implant components are provided sterile.
Ask a Question
Ask a specific question about this device
Page 1 of 1