Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Device Code: 4610

Product Code(s): LZY

Device Classification Information

• Device Type ID: 4610
• Device Name: Prosthesis, Hip, Hemi-, Femoral, Metal Ball
• Regulation Description: Hip Joint Femoral (hemi-hip) Metallic Cemented Or 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 Two ¿ Hips/Wrists/Fingers (JFDB2)
• Submission Type: 510(k)
• CFR Regulation Number: 888.3360 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LZY
• 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
• 11-306 ASTM F1814-15
  Standard Guide For Evaluating Modular Hip And Knee Joint Components

Total Product Life Cycle

• Device Type ID: 4610
• Device: Prosthesis, Hip, Hemi-, Femoral, Metal Ball
• Product Code: LZY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented Prosthesis.
• CFR Regulation Number: 888.3360 [🔎]

Device Problems
Insufficient Information	188
Device Dislodged Or Dislocated	50
Adverse Event Without Identified Device Or Use Problem	28
Appropriate Term/Code Not Available	11
Naturally Worn	3
Break	1
Inadequacy Of Device Shape And/or Size	1
Disassembly	1
Total Device Problems	283

TPLC Last Update: 2019-04-02 20:52:44