FDA product code HTS: Knife, Orthopedic
HTS is the FDA product code for knife, orthopedic. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 9 510(k) submissions under HTS, from 6 different applicants. The average 510(k) review took 98 days (median 48). FDA has posted 3 recalls for HTS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Knife, 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 HTS clearance
Top HTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthropedics, Inc. | 4 | 1987-11-02 |
| Associated Medical Products Co. | 1 | 1994-02-22 |
| Acufex Microsurgical, Inc. | 1 | 1994-01-26 |
| Karlin Technology, Inc. | 1 | 1988-09-22 |
| Medtech Industries, Inc. | 1 | 1984-08-14 |
1 more applicants have HTS clearances. See the full list in Caduvo.
Most recent HTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930507 | Associated Medical Products Co. | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | 1994-02-22 | 386 |
| K933921 | Acufex Microsurgical, Inc. | ACUFLEX DISPOSABLE KNIVES | 1994-01-26 | 169 |
| K882525 | Karlin Technology, Inc. | SPINAL MICROKNIFE | 1988-09-22 | 97 |
| K873714 | Arthropedics, Inc. | BANANA KNIFE, DISPOSABLE #TM-1612 | 1987-11-02 | 48 |
| K873711 | Arthropedics, Inc. | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | 1987-11-02 | 48 |
Recalls for HTS devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-30.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code HTS?
HTS is the FDA product code for knife, orthopedic. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTS?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTS?
Across 9 cleared submissions the average was 98 days from receipt to decision (median 48).
Which companies have the most HTS clearances?
Arthropedics, Inc. (4); Associated Medical Products Co. (1); Acufex Microsurgical, Inc. (1); Karlin Technology, Inc. (1); Medtech Industries, Inc. (1).
Have HTS devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code HTS
- Run a recall and safety report across every HTS manufacturer
- Watch product code HTS 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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