FDA product code HXK: Holder, Needle; Orthopedic
HXK is the FDA product code for holder, needle; orthopedic. 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 HXK, from 5 different applicants. The average 510(k) review took 32 days (median 25). FDA has posted 5 recalls for HXK devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Needle; 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 HXK clearance
Top HXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dhason Brothers, Inc. | 1 | 1989-02-03 |
| Micrins Surgical, Inc. | 1 | 1987-08-21 |
| Buckman Co., Inc. | 1 | 1986-02-07 |
| Ace Orthopedic Manufacturing Co. | 1 | 1980-09-09 |
| Edward Weck, Inc. | 1 | 1978-01-20 |
Most recent HXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890167 | Dhason Brothers, Inc. | HOLDER, NEEDLE | 1989-02-03 | 25 |
| K872989 | Micrins Surgical, Inc. | MICRINS NEEDLE HOLDER | 1987-08-21 | 21 |
| K860018 | Buckman Co., Inc. | FISCHER WIRE/PIN CLAMP | 1986-02-07 | 35 |
| K801594 | Ace Orthopedic Manufacturing Co. | ACE FISCHER EXTERNAL FIXATION DEVICE | 1980-09-09 | 57 |
| K772388 | Edward Weck, Inc. | CONVERSE-GILLIES NEEDLE HOLDER | 1978-01-20 | 24 |
Recalls for HXK devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HXK?
HXK is the FDA product code for holder, needle; orthopedic. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXK?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXK?
Across 5 cleared submissions the average was 32 days from receipt to decision (median 25).
Which companies have the most HXK clearances?
Dhason Brothers, Inc. (1); Micrins Surgical, Inc. (1); Buckman Co., Inc. (1); Ace Orthopedic Manufacturing Co. (1); Edward Weck, Inc. (1).
Have HXK devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HXK
- Run a recall and safety report across every HXK manufacturer
- Watch product code HXK 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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