FDA product code HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
HSX is the FDA product code for prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3520 and reviewed by the Orthopedic panel. FDA has cleared 114 510(k) submissions under HSX, 12 in the last five years, from 46 different applicants. The average 510(k) review took 111 days (median 88); 83 days on average over the last three years. FDA has posted 104 recalls for HSX devices, 39 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3520 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HSX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 173 |
| 2018 | 2 | 140 |
| 2019 | 7 | 113 |
| 2020 | 4 | 38 |
| 2021 | 7 | 97 |
| 2022 | 2 | 172 |
| 2023 | 1 | 310 |
| 2024 | 4 | 139 |
| 2025 | 4 | 89 |
| 2026 | 1 | 22 |
Top HSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 13 | 2024-10-30 |
| Zimmer, Inc. | 9 | 2020-03-17 |
| Conformis, Inc. | 8 | 2013-12-05 |
| Bodycad Laboratories, Inc. | 7 | 2021-10-12 |
| Medacta International S.A. | 5 | 2025-07-24 |
41 more applicants have HSX clearances. See the full list in Caduvo.
Most recent HSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260796 | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Tahoe Unicondylar Knee System with TiNbN Overcoat | 2026-04-02 | 22 |
| K251771 | Signature Orthopaedics Pty, Ltd. | Cambridge Partial Knee | 2025-12-16 | 189 |
| K251834 | Zimmer Biomet | Persona Partial Knee | 2025-08-15 | 60 |
| K251618 | Medacta International S.A. | MOTO Partial Knee System Extension | 2025-07-24 | 58 |
| K251453 | Arthrex, Inc. | Arthrex iBalance Partial Knee System | 2025-07-01 | 50 |
Recalls for HSX devices
104 product recalls in 19 recall events; 39 initiated in the last five years and 41 still open. Most recent: 2023-05-02.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2020 | 4 |
| 2023 | 39 |
Frequently asked questions
What is FDA product code HSX?
HSX is the FDA product code for prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3520 and reviewed by the Orthopedic panel.
What device class is HSX?
Class II, regulation 21 CFR 888.3520. Typical premarket route: 510(k).
How long does a 510(k) take for product code HSX?
Across 114 cleared submissions the average was 111 days from receipt to decision (median 88).
Which companies have the most HSX clearances?
Smith & Nephew, Inc. (13); Zimmer, Inc. (9); Conformis, Inc. (8); Bodycad Laboratories, Inc. (7); Medacta International S.A. (5).
Have HSX devices been recalled?
Yes: 104 product recalls across 19 recall events; the most recent began 2023-05-02.
Next steps
- Run an FDA pathway report with predicate devices for product code HSX
- Run a recall and safety report across every HSX manufacturer
- Watch product code HSX 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.