HSX · Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Orthopedic · 21 CFR 888.3520 · Class 2
Overview
| Product Code | HSX |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Regulation | 21 CFR 888.3520 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Recent Cleared Devices (20 of 114)
Showing 20 most recent of 114 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Apr 2, 2026 | SESE |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | Dec 16, 2025 | SESE |
| K251834 | Persona Partial Knee | Zimmer Biomet | Aug 15, 2025 | SESE |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | Jul 24, 2025 | SESE |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | Jul 1, 2025 | SESE |
| K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | Dec 6, 2024 | SESE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | Oct 30, 2024 | SESE |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | Oct 7, 2024 | SESE |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | Apr 4, 2024 | SESE |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | Mar 10, 2023 | SESE |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | Jun 16, 2022 | SESE |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | Jun 2, 2022 | SESE |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | Dec 16, 2021 | SESE |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | Nov 16, 2021 | SESE |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Oct 12, 2021 | SESE |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | Sep 16, 2021 | SESE |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Aug 20, 2021 | SESE |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Mar 12, 2021 | SESE |
| K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | Jan 8, 2021 | SESE |
| K203099 | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Oct 27, 2020 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 13 clearances
- Zimmer, Inc. — 9 clearances
- Conformis, Inc. — 8 clearances
- Bodycad Laboratories, Inc. — 7 clearances
- Depuy, Inc. — 5 clearances
