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510(k) Data Aggregation
K Number
K150496Device Name
Total Knee Arthroplasty System
Manufacturer
Date Cleared
2015-06-12
(107 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Responsive Orthopedics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- · inflammatory degenerative joint disease including rheumatoid arthritis;
- · correction of functional deformity:
- · revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.
Device Description
The Responsive Orthopedics Total Knee Arthroplasty System is a total knee system for the restoration of alignment, stability and range of motion, and alleviation of pain, by replacing the articulating surfaces of the knee joint. The system includes femoral, tibial and patellar components available in cruciate retaining, ultra-conforming cruciate sacrificing, medial-pivot cruciate sacrificing and posterior stabilizing versions.
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