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510(k) Data Aggregation
K Number
K072704Device Name
UNICOMPARTMENTAL KNEE
Manufacturer
VALPO ORTHOPEDIC TECHNOLOGY, INC.
Date Cleared
2008-02-19
(148 days)
Product Code
HRY
Regulation Number
888.3530Why did this record match?
Applicant Name (Manufacturer) :
VALPO ORTHOPEDIC TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.
Device Description
The VOT Uni Knec consists of a femoral and a tibial component. The low profiled prosthesis is designed to be nonconstraining and to allow natural weight distribution and flexion. The anatomically designed femoral component is asymmetrically shaped conforming to the natural knee in the coronal and sagittal planes. The post and keel are designed to provide anteroposterior and mediolateral stability. Cobalt Chrome Alloy is used to fabricate the component which is available in three sizes. The tibial component is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPe). It incorporates a hemispherical shaped articular surface to replicate the natural knce. The component is nonconstraining and designed to allow natural weight distribution and flexion. Dovetailed channels on the undersurface allow for mechanical lock between the implant and the cement mantle. The thickness of the component under the area of the femoral-tibial articulation helps to improve longevity and to minimize the possibility of its fracture. The dual injection ports, the cement delivery instruments, synnge and adapter facilitate cement application. Nine sizes are available to enhance surgical latitude in preoperative planning. Tibial and femoral instruments and trials are also available to facilitate implantation.
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K Number
K062734Device Name
ADJUST-RIGHT FIXATION DEVICES
Manufacturer
VALPO ORTHOPEDIC TECHNOLOGY, INC.
Date Cleared
2006-11-22
(70 days)
Product Code
JDR, HWC, MBI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
VALPO ORTHOPEDIC TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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