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510(k) Data Aggregation
K Number
K020214Device Name
MEDIAL ROTATION KNEE SYSTEM
Manufacturer
ENGINEERING CONSULTING SERVICES, INC.
Date Cleared
2002-02-26
(35 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERING CONSULTING SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medial Rotation Knee™ System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for the reduction in relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
• Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis
• Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of varus, valgus, or post traumatic deformity
• Correction or revision of unsuccessful osteotomy or arthrodesis
• Revision procedures where other treatments or devices have failed
• Treatment of fractures that are unmanageable using other techniques
Device Description
The Medial Rotation Knee™ System is both a primary and revision total knee system composed of a CoCr Femoral component mating with a stemmed CoCr metal backed polyethylene Tibial and all-poly Patella components. The conguency in tibialfemoral and patellafemoral articulation allow for natural knee movement and ROM while minimizing polyethelene wear.
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