FDA product code HTG: Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
HTG is the FDA product code for prosthesis, knee, hemi-, patellar resurfacing, uncemented. It is a Class II device, regulated under 21 CFR 888.3580 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under HTG, from 2 different applicants. The average 510(k) review took 18 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3580 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every HTG clearance
Top HTG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Waldemar Link GmbH & Co. KG | 1 | 1980-04-21 |
| Depuy, Inc. | 1 | 1977-10-06 |
Most recent HTG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K800800 | Waldemar Link GmbH & Co. KG | PATELLAR COMPONENT FOR LUBINUS PATELLAR | 1980-04-21 | 11 |
| K771708 | Depuy, Inc. | WORRELL PATELLA | 1977-10-06 | 24 |
Recalls for HTG devices
openFDA lists no recalls for product code HTG.
Frequently asked questions
What is FDA product code HTG?
HTG is the FDA product code for prosthesis, knee, hemi-, patellar resurfacing, uncemented. It is a Class II device, regulated under 21 CFR 888.3580 and reviewed by the Orthopedic panel.
What device class is HTG?
Class II, regulation 21 CFR 888.3580. Typical premarket route: 510(k).
How long does a 510(k) take for product code HTG?
Across 2 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most HTG clearances?
Waldemar Link GmbH & Co. KG (1); Depuy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HTG
- Run a recall and safety report across every HTG manufacturer
- Watch product code HTG 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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