FDA product code HTO: Reamer
HTO is the FDA product code for reamer. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 14 510(k) submissions under HTO, from 11 different applicants. The average 510(k) review took 56 days (median 30). FDA has posted 83 recalls for HTO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Reamer |
| 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 HTO clearance
Top HTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 3 | 2005-03-16 |
| Depuy, Inc. | 2 | 1979-06-27 |
| Synthes (USA) Products, LLC | 1 | 2011-08-10 |
| Zimmer, Inc. | 1 | 1995-12-28 |
| Onyx Medical Corp. | 1 | 1990-07-30 |
6 more applicants have HTO clearances. See the full list in Caduvo.
Most recent HTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111437 | Synthes (USA) Products, LLC | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | 2011-08-10 | 78 |
| K042899 | Synthes (Usa) | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | 2005-03-16 | 147 |
| K013527 | Synthes (Usa) | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | 2001-12-21 | 59 |
| K993335 | Synthes (Usa) | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | 2000-06-12 | 252 |
| K954915 | Zimmer, Inc. | FLEXIBLE INTRAMEDULLARY REAMER | 1995-12-28 | 63 |
Recalls for HTO devices
83 product recalls in 29 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2024-01-24.
| Year | Recalls |
|---|---|
| 2017 | 8 |
| 2018 | 1 |
| 2020 | 18 |
| 2022 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HTO?
HTO is the FDA product code for reamer. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTO?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTO?
Across 14 cleared submissions the average was 56 days from receipt to decision (median 30).
Which companies have the most HTO clearances?
Synthes (Usa) (3); Depuy, Inc. (2); Synthes (USA) Products, LLC (1); Zimmer, Inc. (1); Onyx Medical Corp. (1).
Have HTO devices been recalled?
Yes: 83 product recalls across 29 recall events; the most recent began 2024-01-24.
Next steps
- Run an FDA pathway report with predicate devices for product code HTO
- Run a recall and safety report across every HTO manufacturer
- Watch product code HTO 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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