Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Product Classification
FDA Home
Medical Devices
Databases
-
New Search
Back to Search Results
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 Code
KMD
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
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-362 ISO 22622 First edition 2019-07
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
11-386 ASTM F2665-21
Standard Specification for Total Ankle Replacement Prosthesis
Third Party Review
Not Third Party Eligible
-
-