HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class II
FDA Device Classification
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 |
|---|
| 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 |
| K202207 | materialise | Materialise PKA Guide System | October 2, 2020 |