Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

Device Code: 4475

Product Code(s): HTG

Device Classification Information

• Device Type ID: 4475
• Device Name: Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
• Regulation Description: Knee Joint Patellar (hemi-knee) Metallic Resurfacing Uncemented 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: 888.3580 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HTG
• 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
• 11-281 ASTM F1672-14
  Standard Specification For Resurfacing Patellar Prosthesis
• 11-306 ASTM F1814-15
  Standard Guide For Evaluating Modular Hip And Knee Joint Components

Total Product Life Cycle

• Device Type ID: 4475
• Device: Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
• Product Code: HTG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Knee Joint Patellar (hemi-knee) Metallic Resurfacing Uncemented Prosthesis.
• CFR Regulation Number: 888.3580 [🔎]

Device Problems
Loose Or Intermittent Connection	9
Insufficient Information	2
Noise, Audible	1
Naturally Worn	1
Fracture	1
Loss Of Or Failure To Bond	1
Total Device Problems	15

TPLC Last Update: 2019-04-02 20:50:03