FDA product code HXA: Prosthesis, Tendon, Passive
HXA is the FDA product code for prosthesis, tendon, passive. It is a Class II device, regulated under 21 CFR 888.3025 and reviewed by the Orthopedic panel. FDA has cleared 11 510(k) submissions under HXA, 1 in the last five years, from 6 different applicants. The average 510(k) review took 103 days (median 88); 63 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Tendon, Passive |
| Device class | Class II |
| Regulation | 21 CFR 888.3025 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HXA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 63 |
Compare with all 510(k) review times · Search every HXA clearance
Top HXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Holter-Hausner Intl. | 6 | 1987-09-28 |
| Askorn Medical | 1 | 2025-01-10 |
| Medist International | 1 | 2000-03-29 |
| Technical Products, Inc. | 1 | 1997-12-05 |
| Avanta Orthopaedics, Inc. | 1 | 1997-03-25 |
1 more applicants have HXA clearances. See the full list in Caduvo.
Most recent HXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243477 | Askorn Medical | Universal Tendon Spacer | 2025-01-10 | 63 |
| K000019 | Medist International | SINGLE SIZE TENDON SPACER | 2000-03-29 | 85 |
| K973385 | Technical Products, Inc. | OVAL SHAPES | 1997-12-05 | 88 |
| K964359 | Avanta Orthopaedics, Inc. | AVANTA ORTHOPAEDICS TENDON SPACER | 1997-03-25 | 144 |
| K930125 | Phoenix Bioengineering, Inc. | PHOENIX BONE SCREWS PBS-TYPE SERIES | 1993-12-30 | 352 |
Recalls for HXA devices
openFDA lists no recalls for product code HXA.
Frequently asked questions
What is FDA product code HXA?
HXA is the FDA product code for prosthesis, tendon, passive. It is a Class II device, regulated under 21 CFR 888.3025 and reviewed by the Orthopedic panel.
What device class is HXA?
Class II, regulation 21 CFR 888.3025. Typical premarket route: 510(k).
How long does a 510(k) take for product code HXA?
Across 11 cleared submissions the average was 103 days from receipt to decision (median 88).
Which companies have the most HXA clearances?
Holter-Hausner Intl. (6); Askorn Medical (1); Medist International (1); Technical Products, Inc. (1); Avanta Orthopaedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HXA
- Run a recall and safety report across every HXA manufacturer
- Watch product code HXA 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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