Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
A femorotibial knee prosthesis, semi-constrained, cemented, trunnion-bearing type is a surgically implanted orthopedic device used to replace the articulating surfaces of the knee joint in patients with severe arthritis, trauma, or other conditions causing knee joint destruction; the trunnion-bearing design allows controlled rotational motion within the implant. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LGE and is regulated under 21 CFR 888.3530 within the Orthopedic specialty. This device is flagged as an implant, as it is permanently placed within the body.
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Basic Information
- Product Code
- LGE
- Device Class
- FDA class 2
- Regulation Number
- 888.3530
- 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 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.