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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, semi-constrained, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer
Regulation Description Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
Definition Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Product CodeNJD
Regulation Number 888.3535
Device Class 2

Premarket Reviews

Device Problems
No Information 1
No code available 1
Total Device Problems 2