HSX
- Product code
- HSX
- Device name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3520
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 115 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261609 | 2026-08-04 | Maxx Orthopedics, Inc. | Freedom Partial Knee System | |
| K260796 | 2026-04-02 | Shalby Advanced Technologies, Inc. Dba… | Tahoe Unicondylar Knee System with TiNbN Overcoat | |
| K251771 | 2025-12-16 | Signature Orthopaedics Pty, Ltd. | Cambridge Partial Knee | |
| K251834 | 2025-08-15 | Zimmer Biomet | Persona Partial Knee | |
| K251618 | 2025-07-24 | Medacta International S.A. | MOTO Partial Knee System Extension | FDA |
| K251453 | 2025-07-01 | Arthrex, Inc. | Arthrex iBalance Partial Knee System | |
| K241260 | 2024-12-06 | Globus Medical, Inc. | ACTIFY Unicondylar Knee System | |
| K242711 | 2024-10-30 | Smith & Nephew, Inc. | JOURNEY II Unicompartmental Knee System (JOURNEY II … | |
| K242746 | 2024-10-07 | Overture Orthopaedics | OvertureTi Knee Resurfacing SystemTM | |
| K232114 | 2024-04-04 | Kyocera Medical Technologies, Inc. | TRIBRID® Unicompartmental Knee System |
Official FDA classification page: HSX
Classification and pathway per current FDA publications. Data from openFDA (CC0).