FDA product code LGE: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
LGE is the FDA product code for prosthesis, knee, femorotibial, semi-constrained, cemented, trunnion-bearing. It is a Class II device, regulated under 21 CFR 888.3530 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under LGE, from 2 different applicants. The average 510(k) review took 26 days (median 26). FDA has posted 1 recall for LGE devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing |
| Device class | Class II |
| Regulation | 21 CFR 888.3530 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LGE clearance
Top LGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Osteonics Corp. | 1 | 1999-08-12 |
| Howmedica Corp. | 1 | 1981-07-01 |
Most recent LGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992346 | Howmedica Osteonics Corp. | KINEMATIC II ROTATING HINGE KNEE | 1999-08-12 | 30 |
| K811630 | Howmedica Corp. | KINEMATIC ROTATING HINGE TOTAL KNEE PR. | 1981-07-01 | 22 |
Recalls for LGE devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code LGE?
LGE is the FDA product code for prosthesis, knee, femorotibial, semi-constrained, cemented, trunnion-bearing. It is a Class II device, regulated under 21 CFR 888.3530 and reviewed by the Orthopedic panel.
What device class is LGE?
Class II, regulation 21 CFR 888.3530. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGE?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most LGE clearances?
Howmedica Osteonics Corp. (1); Howmedica Corp. (1).
Have LGE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LGE
- Run a recall and safety report across every LGE manufacturer
- Watch product code LGE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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