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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, ankle, semi-constrained, cemented, metal/composite
Regulation Description Ankle joint metal/composite semi-constrained cemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKMD
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3100
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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