Prosthesis, Ankle, Semi-constrained, Cemented, Metal/composite

Device Code: 4548

Product Code(s): KMD

Device Classification Information

• Device Type ID: 4548
• Device Name: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/composite
• Regulation Description: Ankle Joint Metal/composite Semi-constrained Cemented Prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 888.3100 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KMD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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
• 11-234 ASTM F732-00 (Reapproved 2011)
  Standard Test Method For Wear Testing Of Polymeric Materials Used In Total Joint Prostheses
• 11-266 ASTM F2665-09 (Reapproved 2014)
  Standard Specification For Total Ankle Replacement Prosthesis
• 11-342 ASTM F732-17
  Standard Test Method For Wear Testing Of Polymeric Materials Used In Total Joint Prostheses

Total Product Life Cycle

• Device Type ID: 4548
• Device: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/composite
• Product Code: KMD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ankle Joint Metal/composite Semi-constrained Cemented Prosthesis.
• CFR Regulation Number: 888.3100 [🔎]

TPLC Last Update: 2019-04-02 20:51:29