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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
Physical State May include: Femoral Component Tibial Component Metal Backed Patellar Component Tibial Insert Patella Insert All Poly Patellar Component Instrumentation
Technical Method This device is intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prosthesis that have a femoral component mode of alloys, such as cobalt-chromium-molybdenum, and a tibial component(s) and/or a retropatellar resurfacing component made of ultra-high molecular weight polyethylene plus an additive, such as a-tocopherol.
Target Area Knee
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOIY
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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