Ankle Arthroplasty Implantation System

Device Code: 4675

Product Code(s): OYK

Definition: Intended To Be Used To Assist In The Implantation Of A Specific Ankle Arthroplasty Device. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, And Sizing.

Device Classification Information

• Device Type ID: 4675
• Device Name: Ankle Arthroplasty Implantation System
• Physical State: A Device Accessory Or A Set Of Device Accessories.
• Technical Method: Aids The Surgeon In Performing The Implantation Of An Ankle Arthroplasty Device.
• Target Area: Ankle
• Regulation Description: Ankle Joint Metal/polymer 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 Two ¿ Hips/Wrists/Fingers (JFDB2)
• Submission Type: 510(k)
• CFR Regulation Number: 888.3110 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OYK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-423 ASTM F2565-13
  Standard Guide For Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms For Surgical Implant Applications
• 8-424 ASTM F2695-12
  Standard Specification For Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) And Fabricated Forms For Surgical Implant Applications

Total Product Life Cycle

• Device Type ID: 4675
• Device: Ankle Arthroplasty Implantation System
• Product Code: OYK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ankle Joint Metal/polymer Semi-constrained Cemented Prosthesis.
• CFR Regulation Number: 888.3110 [🔎]

TPLC Last Update: 2019-04-02 20:53:46