FDA product code HXI: Passer, Wire, Orthopedic
HXI is the FDA product code for passer, wire, orthopedic. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under HXI, from 2 different applicants. The average 510(k) review took 39 days (median 21). FDA has posted 8 recalls for HXI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Passer, Wire, Orthopedic |
| 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 HXI clearance
Top HXI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bowen & Company, Inc. | 2 | 1986-09-05 |
| Safewire, LLC | 1 | 2014-05-20 |
Most recent HXI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140576 | Safewire, LLC | Y WIRE 2 | 2014-05-20 | 75 |
| K863146 | Bowen & Company, Inc. | BOWEN SUTURE PASSER | 1986-09-05 | 21 |
| K863148 | Bowen & Company, Inc. | BOWEN KNOT PASSER | 1986-09-05 | 21 |
Recalls for HXI devices
8 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-06-17.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code HXI?
HXI is the FDA product code for passer, wire, orthopedic. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXI?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXI?
Across 3 cleared submissions the average was 39 days from receipt to decision (median 21).
Which companies have the most HXI clearances?
Bowen & Company, Inc. (2); Safewire, LLC (1).
Have HXI devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2026-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code HXI
- Run a recall and safety report across every HXI manufacturer
- Watch product code HXI 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times