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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, knee, femorotibial, 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.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNJD
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3535
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible