Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
An uncemented patellar resurfacing hemi-knee prosthesis is a surgically implanted device used to replace the articular surface of the patella without the use of bone cement, relying on bone ingrowth or press-fit fixation, typically used in partial knee replacement procedures. It is classified as an FDA Class 2 device under 21 CFR 888.3580, indicating moderate risk and requiring 510(k) premarket clearance. Product code HTG falls under the Orthopedic medical specialty. This device is an implant.
Basic Information
- Product Code
- HTG
- Device Class
- FDA class 2
- Regulation Number
- 888.3580
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.