FDA product code HXJ: Staple Driver
HXJ is the FDA product code for staple driver. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under HXJ, from 5 different applicants. The average 510(k) review took 88 days (median 66). FDA has posted 2 recalls for HXJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Staple Driver |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Top HXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Influence, Inc. | 2 | 1997-02-13 |
| Micro Surgical Instruments Corp. | 1 | 1993-08-02 |
| Stryker Corp. | 1 | 1984-04-23 |
| Instrument Makar, Inc. | 1 | 1983-03-09 |
| Techmedica, Inc. | 1 | 1983-03-09 |
Most recent HXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964953 | Influence, Inc. | IN-TAC BONE ANCHOR SYSTEM | 1997-02-13 | 70 |
| K962372 | Influence, Inc. | UROTAC BONE ANCHOR INSERTER | 1996-08-19 | 61 |
| K930205 | Micro Surgical Instruments Corp. | ELECTRIC WIRE DRIVER, MODEL 2640E | 1993-08-02 | 199 |
| K834515 | Stryker Corp. | FIXATION STAPLE KIT - DLIDE HAMMER | 1984-04-23 | 124 |
| K830456 | Instrument Makar, Inc. | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | 1983-03-09 | 28 |
Recalls for HXJ devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-05-17.
Frequently asked questions
What is FDA product code HXJ?
HXJ is the FDA product code for staple driver. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXJ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXJ?
Across 6 cleared submissions the average was 88 days from receipt to decision (median 66).
Which companies have the most HXJ clearances?
Influence, Inc. (2); Micro Surgical Instruments Corp. (1); Stryker Corp. (1); Instrument Makar, Inc. (1); Techmedica, Inc. (1).
Have HXJ devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2006-05-17.
Next steps
- Run an FDA pathway report with predicate devices for product code HXJ
- Run a recall and safety report across every HXJ manufacturer
- Watch product code HXJ 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.