FDA product code HTX: Rongeur
HTX is the FDA product code for rongeur. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under HTX, from 4 different applicants. The average 510(k) review took 71 days (median 28). FDA has posted 7 recalls for HTX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Rongeur |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTX clearance
Top HTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plastafil, Inc. | 2 | 1984-09-20 |
| Solway, Inc. | 1 | 1987-12-30 |
| Orthopedic Equipment Co., Inc. | 1 | 1978-03-22 |
| Depuy, Inc. | 1 | 1976-08-03 |
Most recent HTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874954 | Solway, Inc. | MANUAL RONGEUR | 1987-12-30 | 28 |
| K841621 | Plastafil, Inc. | BACK RADIUS CUTTER | 1984-09-20 | 154 |
| K841620 | Plastafil, Inc. | FRONT RADIUS CUTTER | 1984-09-20 | 154 |
| K780397 | Orthopedic Equipment Co., Inc. | ORTHOPEDIC FORCEPS | 1978-03-22 | 9 |
| K760325 | Depuy, Inc. | SURGICAL INSTRUMENTS, ORTHOPEDIC | 1976-08-03 | 8 |
Recalls for HTX devices
7 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HTX?
HTX is the FDA product code for rongeur. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTX?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTX?
Across 5 cleared submissions the average was 71 days from receipt to decision (median 28).
Which companies have the most HTX clearances?
Plastafil, Inc. (2); Solway, Inc. (1); Orthopedic Equipment Co., Inc. (1); Depuy, Inc. (1).
Have HTX devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HTX
- Run a recall and safety report across every HTX manufacturer
- Watch product code HTX 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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