FDA product code HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
HSD is the FDA product code for prosthesis, shoulder, hemi-, humeral, metallic uncemented. It is a Class II device, regulated under 21 CFR 888.3690 and reviewed by the Orthopedic panel. FDA has cleared 71 510(k) submissions under HSD, 2 in the last five years, from 41 different applicants. The average 510(k) review took 120 days (median 88); 136 days on average over the last three years. FDA has posted 19 recalls for HSD devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3690 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HSD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 110 |
| 2020 | 2 | 359 |
| 2022 | 1 | 20 |
| 2024 | 1 | 136 |
Compare with all 510(k) review times · Search every HSD clearance
Top HSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Osteonics Corp. | 6 | 2007-05-04 |
| Arthrex, Inc. | 5 | 2024-02-12 |
| Exactech, Inc. | 4 | 2013-11-26 |
| DePuy Orthopaedics, Inc. | 4 | 2008-12-18 |
| Biomet, Inc. | 4 | 2005-09-29 |
36 more applicants have HSD clearances. See the full list in Caduvo.
Most recent HSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233260 | Arthrex, Inc. | Univers Revers CA Head and Adapter | 2024-02-12 | 136 |
| K221232 | Arthrex, Inc. | Univers Revers Humeral Cup Implant | 2022-05-19 | 20 |
| K191433 | Implantcast GmbH | AGILON® XO Shoulder Replacement System | 2020-11-12 | 533 |
| K193122 | Biocore9, LLC | Biocore9 Humeral Resurfacing System | 2020-05-15 | 185 |
| K173964 | Arthrosurface, Inc. | OVOMotion Shoulder Arthroplasty System | 2018-04-18 | 110 |
Recalls for HSD devices
19 product recalls in 12 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-11-09.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 3 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code HSD?
HSD is the FDA product code for prosthesis, shoulder, hemi-, humeral, metallic uncemented. It is a Class II device, regulated under 21 CFR 888.3690 and reviewed by the Orthopedic panel.
What device class is HSD?
Class II, regulation 21 CFR 888.3690. Typical premarket route: 510(k).
How long does a 510(k) take for product code HSD?
Across 71 cleared submissions the average was 120 days from receipt to decision (median 88).
Which companies have the most HSD clearances?
Howmedica Osteonics Corp. (6); Arthrex, Inc. (5); Exactech, Inc. (4); DePuy Orthopaedics, Inc. (4); Biomet, Inc. (4).
Have HSD devices been recalled?
Yes: 19 product recalls across 12 recall events; the most recent began 2020-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code HSD
- Run a recall and safety report across every HSD manufacturer
- Watch product code HSD 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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