Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)

Device Code: 4469

Product Code(s): HSH

Device Classification Information

• Device Type ID: 4469
• Device Name: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
• Regulation Description: Knee Joint Tibial (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: 888.3590 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HSH
• 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: 4469
• Device: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
• Product Code: HSH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Knee Joint Tibial (hemi-knee) Metallic Resurfacing Uncemented Prosthesis.
• CFR Regulation Number: 888.3590 [🔎]

Device Problems
Insufficient Information	4
Detachment Of Device Component	3
Loss Of Or Failure To Bond	3
Appropriate Term/Code Not Available	2
Failure To Adhere Or Bond	2
Migration Or Expulsion Of Device	1
Naturally Worn	1
Total Device Problems	16

TPLC Last Update: 2019-04-02 20:49:57