HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class II
FDA product code HSX covers "Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3520. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HSX
- Device Class
- Class II
- Regulation Number
- 888.3520
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260796 | shalby advanced technologies, inc. dba consensus orthopedics | Tahoe Unicondylar Knee System with TiNbN Overcoat | April 2, 2026 |
| K251771 | signature orthopaedics pty | Cambridge Partial Knee | December 16, 2025 |
| K251834 | zimmer biomet | Persona Partial Knee | August 15, 2025 |
| K251618 | medacta international | MOTO Partial Knee System Extension | July 24, 2025 |
| K251453 | arthrex | Arthrex iBalance Partial Knee System | July 1, 2025 |
| K241260 | globus medical | ACTIFY Unicondylar Knee System | December 6, 2024 |
| K242711 | smith and nephew | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | October 30, 2024 |
| K242746 | overture orthopaedics | OvertureTi Knee Resurfacing SystemTM | October 7, 2024 |
| K232114 | kyocera medical technologies | TRIBRID® Unicompartmental Knee System | April 4, 2024 |
| K221292 | overture resurfacing | Uni Knee Resurfacing System | March 10, 2023 |
| K212870 | signature orthopaedics pty | TLC Unicompartmental Knee System | June 16, 2022 |
| K220930 | mako surgical | Restoris Multi-Compartmental Knee System | June 2, 2022 |
| K211471 | ortho development corporation | Balanced Knee System Uni | December 16, 2021 |
| K213071 | medacta international | MOTOTM Partial Knee & MOTO PFJ Systems Extension | November 16, 2021 |
| K212307 | bodycad laboratories | BC Reflex Uni Knee System | October 12, 2021 |
| K211512 | smith and nephew | VISIONAIRE UK Patient Matched Cutting Guides | September 16, 2021 |
| K211895 | bodycad laboratories | BC Reflex Uni Knee System | August 20, 2021 |
| K203697 | bodycad laboratories | BC Reflex Uni Knee System | March 12, 2021 |
| K203341 | implantcast | ACS LD Uni FB Knee System | January 8, 2021 |
| K203099 | howmedica osteonics corp. a.k.a. stryker orthopaedics | Triathlon PKR System | October 27, 2020 |